MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 DEPUY ASR XL FEM IMP SIZE 45; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

Catalog Number 999890145

Device Problems Degraded (1153); Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994)

Event Date 11/09/2021

Event Type  Injury  

Event Description

Patient underwent primary total hip re-pavement on (b)(6) 2009 where an asr resurfacing cup with a corail stem was utilized.Patient has presented with a clunking hip in deep flexion and some pain as well as metallosis.On opening the hip, blackened tissue was evident anterior to the cup.There was some soft tissue impingement with metallosis.This black tissue was removed (pseudo tumor) and the asr 300 shell removed.The asr xl head and sleeve were removed from the stem.Corrosion was evident at the head neck junction.The stem was left in situ and a biomet dual mobility shell implanted with a new 28mm metal head.Doi: (b)(6) 2009, dor: (b)(6) 2021, unknown hip.

Manufacturer Narrative

(b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Additional information received indicated that there was no surgical delay and the affected side involved in this event was the right hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.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 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 device history record (dhr) review for this individual asr component will be carried out at this point in time.

• Brand Name: DEPUY ASR XL FEM IMP SIZE 45
• 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
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12882499
• MDR Text Key: 281325445
• Report Number: 1818910-2021-26366
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K040627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 999890145
• Device Lot Number: 2835747
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ASR 300 SPIKED CUP SIZE 50; CORAIL2 STD SIZE 9; DEPUY ASR XL FEM IMP SIZE 45; LARGE MOD HEAD ADAPT 12/14 +5
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female