MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR IMPLANT 50; ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 999804550

Device Problem Osseointegration Problem (3003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 12/07/2007

Event Type  Injury  

Event Description

Asr index procedure asr xl left hip reason for revision: unknown/na doi: on (b)(6) 2007 , dor: on (b)(6) 2020 (left hip).

Manufacturer Narrative

Product complaint (b)(4) e3 initial reporter occupation: lawyer 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.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undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.Ref.Wwcapa 00780 superseded by mdd capa-001226.Previous investigations that have included device history reviews since the asr platform was launched have shown no indication of deviations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voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Wwcapa 00780 superseded by mdd capa-001226 has been established regarding root cause and/or corrective actions.Further determinations and actions will be documented in the corrective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.Update 9th feb 2021 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 andthe investigation will be re-opened as necessary.No device associated with this report was received for examination.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voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Wwcapa 00780 superseded by mdd capa-001226 was established regarding root cause and/or corrective actions.Reference: mdd capa-001226.Previous investigations that have included device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, if lot codes are provided, no dhr (device history record) review or complaint database search for this individual asr component will be carried out at this time.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.- the device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.- from the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Updated on 08 march 2024 no device associated with this report was received for examination.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ASR ACETABULAR IMPLANT 50
• 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
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18874449
• MDR Text Key: 337317402
• Report Number: 1818910-2024-05524
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 999804550
• Device Lot Number: 2421399
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2007
• 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: TOTAL ASR FEM IMP SIZE 45; UNKNOWN HIP FEMORAL AUGMENT; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention