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 Problem Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Pain (1994); Not Applicable (3189)

Event Date 02/22/2018

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.No 510(k) number provided because this implant product code was sold internationally.It was sold in the us under a different product code.The correction/removal reporting number listed applies to the corresponding product code sold domestically.

Event Description

Surgeon reported to (b)(6): known problem of asr-system with hig cocr levels at mom combination.Indication of change of prosthesis on (b)(6) 2018.Doi:unknown; dor: (b)(6) 2018; unknown hip.

Manufacturer Narrative

Product complaint #
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> pc-(b)(4).Investigation summary
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> the asr platform was voluntarily recalled from the market in (b)(6)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-(b)(4).Ongoing post market surveillance is conducted per our procedures for this product.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

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 (b)(4).Ongoing post market surveillance is conducted per our procedures for this product.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Claim suite alert and surgeon confirmation form received.It is now stated that the patient experienced pain and metallosis prior to the revision surgery.The stem is now being identified as a competitor product.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary the asr platform was voluntarily recalled from the market in (b)(6) 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.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.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.H10 additional narrative: replaced surgical intervention with device revision or replacement.

• 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
• MDR Report Key: 7369211
• MDR Text Key: 103406785
• Report Number: 1818910-2018-56031
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• PMA/PMN Number: K040627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 999890145
• Device Lot Number: 2292972
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ASR ACETABULAR IMPLANT 50; DEPUY ASR XL FEM IMP SIZE 45; LARGE MOD HEAD ADAPT 12/14 +5
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR