MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 ASR ACETABULAR IMPLANT 52; ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 999804652

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Anemia (1706); Pain (1994); Rash (2033); Tissue Damage (2104); Weakness (2145); Toxicity (2333); Injury (2348); Osteolysis (2377); No Code Available (3191)

Event Date 11/28/2013

Event Type  Injury  

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.

Event Description

Initial procedure, (b)(6) 2006 : right total hip arthroplasty of the resurfacing type.It was reported by legal that the patient was revised on (b)(6) 2013 due to suspected metallic erosion on right hip resurfacing prosthesis.Patient was originally implanted with size 46 asr femoral component and size 52 asr acetabular component.Postop diagnosis indicated that there was a right hip pseudotumor and metallosis.Revised with non -depuy synthes product.Devices involved: 9998-04-652 total acetabular implant size 52, lot 1870304; 9998-03-946 femoral implant size 46, lot 2021704.

Manufacturer Narrative

Product complaint #
=
> pc-(b)(4).

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Product complaint # :(b)(4).Investigation summary :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.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa-001226.Ongoing post market surveillance is conducted per our procedures for this product.

• Brand Name: ASR ACETABULAR IMPLANT 52
• 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 INTERNATIONAL LTD. 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7305738
• MDR Text Key: 101252671
• Report Number: 1818910-2018-54321
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2010
• Device Catalogue Number: 999804652
• Device Lot Number: 1870304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2018
• Date Device Manufactured: 04/05/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR