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

Catalog Number 999800754

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Discomfort (2330); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/26/2020

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 claim received.After review of medical record, patient was revised to address right hip metallosis with soft tissue reaction.Patient experienced pain and discomfort and elevated metal ion.Operative findings stated that there was significant corrosion at the head and neck junction of femoral stem.There were sign of pseudotumor.Revision notes stated that synovial fluid was obtain for culture.Doi: (b)(6) 2007; 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 : previous investigations that have included manufacturing record evaluations (mre) since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.

• 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
• MDR Report Key: 12009015
• MDR Text Key: 256499031
• Report Number: 1818910-2021-12769
• 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: other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2012
• Device Catalogue Number: 999800754
• Device Lot Number: 2428973
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2021
• 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 +2; ASR ACETABULAR CUPS 54; ASR UNI FEMORAL IMPL SIZE 47; SUMMIT POR TAPER SZ4 HI OFF; ADAPTER SLEEVES 12/14 +2; ASR ACETABULAR CUPS 54; ASR UNI FEMORAL IMPL SIZE 47; SUMMIT POR TAPER SZ4 HI OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR