MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR CUPS 54; ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 999800754

Device Problem Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Local Reaction (2035); Test Result (2695); Not Applicable (3189); No Code Available (3191)

Event Date 03/02/2018

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 medical records received.After review of medical records the patient was revised due to pain and elevated metal ions.Operative note reported straw colored fluid present in the joint and slightly murky consistent with adverse reaction to metal debris, hypertrophic synovium, pseudotumor, hemosiderin stain, metal staining and some trunnionosis.There was some trunnoinosis and metal debris on the trunnion itself.Another event was reported a competitor head would not stay on the trunnion due to adaptor sleeve size was the wrong size to fit on the trunnion.However, decided not to removed the well fixed stem which may add another hours to the case.The head component that did not fit appropriately during revision was temporary left in the patient and proceeded to a second stage procedure to re-implant the correct sized femoral head (competitor).Doi: (b)(6) 2008; dor: (b)(6) 2018; left hip.

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.  if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ASR ACETABULAR CUPS 54
• Type of Device: ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avaenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9416797
• MDR Text Key: 185094591
• Report Number: 1818910-2019-120747
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Catalogue Number: 999800754
• Device Lot Number: 2553229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2008
• Is the Device Single Use?: No
• 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): Required Intervention
• Patient Age: 68 YR