MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 ASR ACETABULAR CUPS 48; ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 999800748

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371); Loss of Osseointegration (2408); Detachment of Device or Device Component (2907); Naturally Worn (2988); Appropriate Term/Code Not Available (3191)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Injury (2348); Osteolysis (2377); Ambulation Difficulties (2544); Inadequate Osseointegration (2646); Test Result (2695); No Code Available (3191)

Event Date 07/02/2018

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.Recall: z-1749/1816-2011.

Event Description

Asr litigation record received.Litigation alleges cup produced metallic debris, cup detachment, disconnection, loosened acetabulum, pain, abnormal blood metal ions, inhibited ability to walk, and injury.

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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pfs and medical records received.After review of medical records, the patient was revised to address a large posterior pseudotumor, elevated serum cobalt and chromium levels and pain.Intra-operative findings include a large, thick posterior pseudocapsule filled with gray-brown fluid, degenerated gluteus medius tendon, gray-stained and thickened capsular tissue, osteolysis around the acetabular and femoral component and a mild amount of corrosion on the femoral trunnion.

Manufacturer Narrative

Product complaint # : (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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 medwatch, a follow-up medwatch will be filed as appropriate.

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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the 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.Patient code: no code available (3191) is used to capture tendon injury and surgical intervention.

• Brand Name: ASR ACETABULAR CUPS 48
• Type of Device: ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 8013680
• MDR Text Key: 125282992
• Report Number: 1818910-2018-73695
• 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: consumer,other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2013
• Device Catalogue Number: 999800748
• Device Lot Number: 2519788
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR