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

Catalog Number 999800748

Device Problem Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Pain (1994); Discomfort (2330); Test Result (2695); No Code Available (3191)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Asr medical records and implant records received.After review of medical records the patient was revised to address painful and failed right thr.Operative note reported mom hip which had elevated metal ions, clicking, discomfort, synovitis and bursitis of the joint were also noted.There is extensive fluid collection of the hip and staining of tissues suggesting recurrent hemorrhage and adverse reaction.There was lack of ingrowth in the capsule.No lab result provided for metal ion level.Doi: (b)(6) 2009; dor: (b)(6) 2019; right hip.

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.H10 additional 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: 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, a follow-up medwatch will be filed as appropriate.

• 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 road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 9172406
• MDR Text Key: 161722622
• Report Number: 1818910-2019-108763
• 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: other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 999800748
• Device Lot Number: 2858309
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/17/2019
• 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: 50 YR