MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP ACETABULAR CUP

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Nonstandard Device (1420); Loss of Osseointegration (2408); Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Osteolysis (2377); Ambulation Difficulties (2544); Inadequate Osseointegration (2646); Test Result (2695); No Code Available (3191)

Event Date 08/02/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Asr litigation alleges that the cup produced metallic debris and had loosened resulting to pain, abnormal blood metal ion levels and walking difficulty.Doi: (b)(6) 2007; dor: (b)(6) 2017, 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: this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.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 will be filed as appropriate.

Event Description

The patient had difficulty with the hip, his cobalt and chromium ions were elevated and mri showed thickened synovium but no significant soft tissue destruction or large pseudotumor.Previous radiographs showed a lot of osteolysis in the inferior neck and was having increasing pain.After review of the medical records, the patient was revised to address failed metal on metal resurfacing arthroplasty and fracture of the femoral neck.Revision notes reported, he had some moderate trochanteric bursitis which was inflammatory and encountered fluid in the hip joint that was cloudy and stained darkly.There was an appearance of chronic metal on metal debris products with gray and blackish stained tissue.The femoral neck was fractured and the component was grossly loosed and was able to removed a lot of osteolysis.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Patient code: no code available (3191) used to capture the bursitis and device revision or replacement.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: UNKNOWN HIP ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 8607817
• MDR Text Key: 144969133
• Report Number: 1818910-2019-93386
• Device Sequence Number: 0
• Product Code: KWY
• PMA/PMN Number: K040627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/22/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• 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: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: DEPUY ASR FEM IMPLANT SZ 53
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR