MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR IMPLANT 52; ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 999804652

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Fatigue (1849); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Test Result (2695); No Code Available (3191)

Event Date 11/18/2010

Event Type  Injury  

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

Asr revision.Asr unknown.Unknown hip.Reason for revision: unknown.Doi: (b)(6) 2008 - dor: (b)(6) 2010 (unknown hip).Created to capture the ed of (b)(4) (2nd revision), the patient had an asr revision prior to its pinnacle construct revision.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.Ref.Wwcapa 00780 superseded by mdd capa-001226.Previous investigations that have included device history reviews since the asr platform was launched have shown no indication of deviations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.Wwcapa 00780 superseded by mdd capa-001226 has been established regarding root cause and/or corrective actions.Further determinations and actions will be documented in the corrective and preventative action investigation as appropriate.Device history lot : null.Device history batch : null.Device history review : null.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).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Updated 30 july 2020 re-open.The complaint was re-opened upon receiving a claimsuite alert.The information received did not change the original investigation report.H10 additional narrative: added: b5, b7, d11 and h6 (patient codes).Corrected: a2 (date of birth).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Claim letter alleges patient was revised due to high chromium and cobalt metal particles in the blood and metallosis.The patient is seeking compensation for all the damages suffered.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5, b6, h6 (clinical and medical device problem codes).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: e2, e3, g1, h5.E3 initial reporter occupation: (b)(6).

Event Description

Litigation alleges unbearable pains, squeaking noise from prosthetic joint, powerlessness, discomfort, elevated metal ions in the blood and metallosis.The malfunction of the mom prosthesis resulted to higher friction with increased toxic ions.Doi: (b)(6) 2008.Dor: (b)(6) 2010.Right hip.

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, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.Ref.Wwcapa 00780 superseded by mdd capa-001226.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.Wwcapa 00780 superseded by mdd capa-001226 has been established regarding root cause and/or corrective actions.Further determinations and actions will be documented in the corrective and preventative action investigation as appropriate.

• Brand Name: ASR ACETABULAR IMPLANT 52
• 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: 10035650
• MDR Text Key: 190503968
• Report Number: 1818910-2020-11837
• Device Sequence Number: 1
• Product Code: KWA
• 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,Followup,Followup
• Report Date: 04/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2012
• Device Catalogue Number: 999804652
• Device Lot Number: 2516646
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/26/2020
• Initial Date FDA Received: 05/07/2020
• Supplement Dates Manufacturer Received: 05/11/2020; 07/30/2020; 01/12/2021; 02/10/2021
• Supplement Dates FDA Received: 05/13/2020; 08/03/2020; 01/29/2021; 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: CORAIL2 NON COL HO SIZE 13; DEPUY ASR XL FEM IMP SIZE 46; LARGE MOD HEAD ADAPT 12/14 +5
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR