MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 UNKNOWN DEPUY ASR ACETABULAR CUP; HIP ACETABULAR CUP

Catalog Number UNK-ASR

Device Problems Nonstandard Device (1420); Metal Shedding Debris (1804)

Patient Problems Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Pain (1994); Joint Swelling (2356)

Event Date 11/02/2012

Event Type  Injury  

Manufacturer Narrative

No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.Udi: unavailable.Complete product detail has not been received at this time.If further information is received, a follow-up medwatch will be filed as appropriate.

Event Description

Jun 28, 2017: litigation received.Litigation alleges that six months after the surgery, the patient was still reporting pain on his left hip irradiating to the right thigh, a feeling of tumefaction in the joints and difficulty in walking.It also alleges that the patient went for an orthopedic consultation and was diagnosed with inflammatory reaction to the implant.Laboratory results for cobalt/chromium are below 7ug/l.There are no medical records provided.

Manufacturer Narrative

On (b)(6) 2017: litigation received.Litigation alleges that six months after the surgery the patient was still reporting pain on his left hip irradiating to the right thigh, a feeling of tumefaction in the joints and difficulty in walking.It also alleges that the patient went for an orthopedic consultation and was diagnosed with inflammatory reaction to the implant.Laboratory results for cobalt/chromium are below 7ug/l.There are no medical records provided.The reported event has been evaluated and will be monitored.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN DEPUY ASR ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds, leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6744494
• MDR Text Key: 81062202
• Report Number: 1818910-2017-21822
• Device Sequence Number: 0
• Product Code: KWA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/28/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-ASR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR