MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNK HIP FEMORAL HEAD METAL ASR; METAL FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD METAL ASR

Device Problem Naturally Worn (2988)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Asr legal notification received.It was reported that the patient had a series of check for the past years until x-ray and a check of cobalt-chromium shows elevated metal ion level and the implant was worn.The surgeon requested for revision however upon examination an aortic aneurysm was detected and it will not be possible to perform the revision.Doi: (b)(6) 2005 : dor: none reported (unk hip).

Manufacturer Narrative

Product complaint # (b)(4).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 andthe investigation will be re-opened as necessary.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : 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.Investigation section: previous investigations that have included device history reviews since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.Therefore, no dhr (device history record) review for this individual asr component will be carried out at this point in time.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.The investigation to determine root cause was conducted under mdd capa-001226.Ongoing post market surveillance is conducted per our procedures for this product.Root cause category: cause not established.E3 initial reporter occupation: lawyer.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.

• Brand Name: UNK HIP FEMORAL HEAD METAL ASR
• Type of Device: METAL FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10936675
• MDR Text Key: 219308998
• Report Number: 1818910-2020-25974
• Device Sequence Number: 1
• Product Code: KXA
• 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
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD METAL ASR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL SLEEVE ASR; UNKNOWN HIP FEMORAL STEM; UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL SLEEVE ASR; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention