MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR CUPS 56; ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 999800756

Device Problems Use of Device Problem (1670); Malposition of Device (2616)

Patient Problems Foreign Body Reaction (1868); Pyrosis/Heartburn (1883); Pain (1994); Rash (2033); Discomfort (2330); Depression (2361); No Code Available (3191)

Event Date 12/26/2008

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

Medical records received.After review of medical records, it was indicated that the patient had pain and discomfort, the patient was then revised for painful right tha secondary to acetabular malposition.Operative notes reported that there was a significant synovial fluid which was benign in nature.There was a grayish discoloration to some of the tissue, indicating possible metallosis.Visit notes on (b)(6) 2008 reported that patient had weight gain due to inactivity cause by pain, heartburn, hernia, arthritic back-low back, skin rash on lower leg, numbness of right hip of upper leg and thigh and depression.Doi: (b)(6) 2007; dor: (b)(6) 2008; right 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.H10 additional narrative:  added: h6 (device).

• Brand Name: ASR ACETABULAR CUPS 56
• 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
• MDR Report Key: 10148945
• MDR Text Key: 195002254
• Report Number: 1818910-2020-13719
• 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: other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2012
• Device Catalogue Number: 999800756
• Device Lot Number: 2428301
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVES 12/14 +8; ASR ACETABULAR CUPS 56; ASR UNI FEMORAL IMPL SIZE 49; CORAIL AMT COLLAR SIZE 12; ADAPTER SLEEVES 12/14 +8; ASR ACETABULAR CUPS 56; ASR UNI FEMORAL IMPL SIZE 49; CORAIL AMT COLLAR SIZE 12
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR