MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 LARGE MOD HEAD ADAPT 12/14 +5 HIP FEMORAL STEM/SLEEVE

Catalog Number 999800105

Device Problems Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problem Pain (1994)

Event Date 12/01/2016

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4). Investigation summary
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> 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. 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.

Manufacturer Narrative

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

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. The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive. Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions. Ref. Wwcapa (b)(4). Depuy considers the investigation closed at this time. Should the product and/or additional information be received, the investigation will be re-opened.

Event Description

Patient underwent a revision to address alval/soft tissue reaction, pseudotumor, noise, elevated metal ions and pain.

• Brand Name: LARGE MOD HEAD ADAPT 12/14 +5
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 6257851
• MDR Text Key: 189283692
• Report Number: 1818910-2017-11078
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 999800105
• Device Lot Number: 2273902
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011

Patient Treatment Data

Date Received: 01/17/2017 Patient Sequence Number: 1