MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR UNI FEMORAL IMPL SIZE 45; ASR HIP SYSTEM : HIP METAL FEMORAL HEADS

Catalog Number 999890245

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Pocket Erosion (2013); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Test Result (2695); No Code Available (3191)

Event Date 11/07/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (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 claim letter records received.Claim letter has no allegation provided.Shall there be new information this complaint shall be updated accordingly.After review of the medical records, the patient was revised to address pseudotumor with osteolysis and elevated metal ions.Operative note reported significant amount of dark-colored fluid consistent with metalosis and synovitis.Notes also a pseudotumor involving the outer capsule which had eroded most of the posterior capsule and femur.Mri showed a collection of fluid extended outside the joint.No lab result provided for the metal ions.Doi: (b)(6) 2010; dor: (b)(6) 2018; left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : 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 and the investigation will be re-opened as necessary.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information received indicated that following the tha, the patient's thr was due to c/o l hip pain related to asr metal on metal bearing cup.Clinical visits reported discomfort on her left hip and back.

• Brand Name: ASR UNI FEMORAL IMPL 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: 10852523
• MDR Text Key: 216646838
• Report Number: 1818910-2020-24753
• 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
• Report Date: 01/29/2020

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 Catalogue Number: 999890245
• Device Lot Number: 2872820
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 01/13/2021; 04/28/2021
• Supplement Dates FDA Received: 01/13/2021; 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVES 12/14 +2; ASR ACETABULAR CUPS 50; SUMMIT POR TAPER SZ5 HI OFF; ADAPTER SLEEVES 12/14 +2; ASR ACETABULAR CUPS 50; SUMMIT POR TAPER SZ5 HI OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR