Devices › Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Device brand name · Hip prosthesis
Hemi Por Shl W/Sealed Scwhls Sz55mm I-O: medical device reports filed with FDA
156 reports name it, 2000–2003. Manufacturer given most often on reports: Sulzer Orthopedics. Product code LPH.
- 156
- device reports naming the brand
- 0% of all MAUDE reports · about 6 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 0.6%
- classified as malfunction
- 7.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
156 medical device reports received by FDA name the brand "Hemi Por Shl W/Sealed Scwhls Sz55mm I-O" (hip prosthesis); the manufacturer given most often on reports is Sulzer Orthopedics; received from November 2000 to July 2003. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (99.4%) and malfunction (0.6%); across all prosthesis, hip, semi-constrained, metal/polymer, porous uncemented reports (product code LPH) death is recorded in 0.2% and malfunction in 7.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are explanted (85.3%), replace (42.3%) and loose (23.7%). The patient problems coded most often are surgical procedure, repeated, pain and surgical procedure. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
No report naming Hemi Por Shl W/Sealed Scwhls Sz55mm I-O was received in the five years to August 2026; the latest was received in July 2003.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 90,251 reports carrying product code LPH. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Explanted | 133 | 85.3% | 2.3% |
| Replace | 66 | 42.3% | 1% |
| Loose | 37 | 23.7% | 0.9% |
| Contamination | 5 | 3.2% | 0.1% |
| Loose or intermittent connection | 4 | 2.6% | 1.1% |
| Other (for use when an appropriate device code cannot be identified) | 3 | 1.9% | 0.3% |
| Residue after decontamination | 3 | 1.9% | 0% |
| Defective component | 2 | 1.3% | 0% |
| Device issuea problem with the device | 2 | 1.3% | 0.1% |
| Dislocated | 1 | 0.6% | 0.9% |
| Elective removal | 1 | 0.6% | 0% |
| Material erosion | 1 | 0.6% | 2.1% |
| Migration or expulsion of device | 1 | 0.6% | 1% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Surgical procedure, repeated | 105 | 67.3% |
| Painpain, site not specified | 74 | 47.4% |
| Surgical procedure | 28 | 17.9% |
| Failure of implant | 21 | 13.5% |
| Hospitalization required | 17 | 10.9% |
| Therapy/non-surgical treatment, additional | 8 | 5.1% |
| Other (for use when an appropriate patient code cannot be identified) | 7 | 4.5% |
| Ambulation or postural difficulties | 5 | 3.2% |
| Discomfortdiscomfort | 2 | 1.3% |
| Arthritis | 1 | 0.6% |
| Complaint, ill-defined | 1 | 0.6% |
| Impaired healingslow healing | 1 | 0.6% |
| Inflammationinflammation | 1 | 0.6% |
| Loss of range of motion | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Hemi Por Shl W/Sealed Scwhls Sz55mm I-O | Product code LPH | All MAUDE reports |
|---|---|---|---|
| Reports | 156 | 90,251 | 26,136,888 |
| Share of that pool | — | 0.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 99.4% | 91.7% | 36.2% |
| Classified as malfunction | 0.6% | 7.5% | 62.3% |
| Filed by the manufacturer | 100% | 99.1% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code LPH
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Unknown Hip Acetabular Liners | 4,814 | 260 | 0.2% |
| Unknown Hip Acetabular Cup | 3,215 | 106 | 0.4% |
| Apex Hole Elim Positive Stop | 1,082 | 20 | 0.4% |
| Pinn Can Bone Screw 6 5mmx25mm | 1,299 | 32 | 0% |
| Unknown Hip Femoral Stem | 4,140 | 79 | 0.8% |
| Unknown Hip Femoral Head | 5,080 | 176 | 0.7% |
| Pinn Can Bone Screw 6 5mmx20mm | 1,075 | 19 | 0.3% |
| Pinn Can Bone Screw 6 5mmx30mm | 981 | 22 | 0.3% |
| Altrx Neut 36idx52od | 638 | 23 | 0% |
| UNK Hip Femoral Head Ceramic | 720 | 126 | 0.1% |
| Unknown Hip | 2,306 | 5 | 1.9% |
| Trident 0 X3 Insert 36mm Id | 585 | 0 | 0.2% |
| Altrx Neut 36idx54od | 553 | 23 | 0% |
| Altrx Neut 32idx50od | 552 | 21 | 0% |
| Altrx +4 10d 36idx52od | 544 | 17 | 0.2% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Hemi Por Shl W/Sealed Scwhls Sz55mm I-O reports
How many FDA reports name Hemi Por Shl W/Sealed Scwhls Sz55mm I-O?
156 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (99.4%) and malfunction (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
explanted (85.3%), replace (42.3%), loose (23.7%), contamination (3.2%) and loose or intermittent connection (2.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Hemi Por Shl W/Sealed Scwhls Sz55mm I-O was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.