MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Use of Device Problem (1670); Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problems Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Injury (2348); Test Result (2695); No Code Available (3191)

Event Date 09/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

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 malpositioned.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).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9885264
• MDR Text Key: 189446635
• Report Number: 1818910-2020-09412
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR