MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-26 for UNKNOWN HIP FEMORAL HEAD UNK HIP FEMORAL HEAD manufactured by Depuy Orthopaedics Inc Us.
[188874651]
(b)(4). Initial reporter occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[188874652]
Pcf and medical records received. After review of medical records, patient was revised to address failed left total hip replacement. Patient has begun to have problems with the right hip and because of this was metal-on-metal articulation as was the left side. A cobalt and chromium level was obtained, which showed elevation and in addition, a mars mri showed fluid accumulations around both hips with a diagnosis of "pseudotumor" of the hip, especially on the right. Operative notes indicated that when the capsule was opened, there was a rush of green fluid, which was obviously discolored with titanium debris as the cobalt chrome articulation contain no titanium itself. This was quite unusual. Exposure continued with removal of significant amount of granulomatous tissue from inside the hip capsule and this continued down to the femur itself. The posterior wall of the proximal femur was in part missing and this granulomatous tissue had invaded into the greater trochanter. The scar from the previous surgery was taken down in order to dislocate the hip by bringing it to maximum internal rotation. As this was being done, it was evident that there was a "dent' in the neck of the femoral component in an area where it appeared to be impinging posteriorly on the acetabular cup. This again was quite unexpected as was the presence of additional granulomatous material anteriorly and circumferentially around the acetabulum. The femoral head was then removed and the acetabulum carefully examined. This was found to be rnalpositioned. Careful questioning following surgery revealed that during yoga and pilates exercises, she occasionally felt some instability in the hip and a clicking sensation when presumably the femoral neck impacted the acetabular cup. Once the femur had been subluxed anteriorly and the cup was carefully examined, it was found to be extending over the posterior wall of the acetabulum by at least 10 mm. Additionally palpating the cup anteriorly, it was possible to palpate approximately the same amount of anterior wall clearly indicating that the cup had been malpositioned. Further the acetabular liner was loose and was easily extracted. This was again very surprising finding, but apparently answered the question of the origin of the titanium debris as the cup liner had been moving inside the titanium cup and be very hard cobalt chrome has had obviously been abrading the titanium shell. Several scenarios were then considered including leaving the cup in place and replacing this with a plastic liner. It was finally elected to remove the malpositioned cup and replaced this with one in better location. This was done in a standard manner by undermining the bone ingrowth with curved osteotomes from the grey revision instrument set. This was done as atraumatically as possible, but resulted in a loss of some medial bone stock in the area of the old transverse acetabular ligament. Doi: (b)(6) 2004; dor: (b)(6) 2018 (left hip).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-09410 |
| MDR Report Key | 9885174 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-10 |
| Date of Event | 2018-09-26 |
| Date Mfgr Received | 2020-03-10 |
| Date Added to Maude | 2020-03-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465810988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN HIP FEMORAL HEAD |
| Generic Name | HIP FEMORAL HEAD |
| Product Code | KXA |
| Date Received | 2020-03-26 |
| Catalog Number | UNK HIP FEMORAL HEAD |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS INC US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-26 |