MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR UNI FEMORAL IMPL SIZE 47; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

Catalog Number 999890247

Device Problems Degraded (1153); Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Osteolysis (2377); Unspecified Tissue Injury (4559); Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/14/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter 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 record received.After review of medical record patient was revised to address metallosis.Revision notes stated that head was removed with evidenced of corrosion.Soft tissue at the periphery of the acetabular component was removed, after which the curved acetabular osteotomes were used to remove the acetabular component with minimal bone loss.There was a contained defect in the ischium which did not involve the cortex.The greated trochanter had some osteolysis secondary to metal debris but was intact.Limb lengths were improved from the 9 mm short that the patient was before.Doi: (b)(6) 2008.Dor: (b)(6) 2020, (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.Device history lot : the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.An mre (device history record) review will not be performed even when lot code(s) are known.

• Brand Name: ASR UNI FEMORAL IMPL SIZE 47
• Type of Device: ASR HIP SYSTEM : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 12576502
• MDR Text Key: 274737313
• Report Number: 1818910-2021-21934
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K040627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2012
• Device Catalogue Number: 999890247
• Device Lot Number: 2445346
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/26/2021
• 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 +5; ASR ACETABULAR CUPS 54; ASR UNI FEMORAL IMPL SIZE 47; CORAIL2 LAT COXA VARA SIZE 15; ADAPTER SLEEVES 12/14 +5; ASR ACETABULAR CUPS 54; ASR UNI FEMORAL IMPL SIZE 47; CORAIL2 LAT COXA VARA SIZE 15
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR