MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ENDURANCE CALCAR SZ3 200MM; MISCELLANEOUS HIP STEM : HIP FEMORAL STEM

Catalog Number	152162000
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	10/29/2014
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
(b)(4).Litigation alleges that patient experienced hip pain, causing difficulty ambulating and sleeping.Additionally, it is alleged that implant is releasing metal ions into patient's body.Doi: unknown - dor: none reported (right side).(b)(6).Update dec 05, 2017: pfs and medical records received.In addition to what were previously alleged, pfs alleges injury and limited mobility.After the review of medical records for mdr reportability, it was stated that the patient was revised to address femoral and acetabular component loosening.Revision notes reported grossly loose femoral component.Clinical notes reported of leg length discrepancy, osteonecrosis, antalgic gait, decreased range of motion, bursitis and tenderness.Laboratory result for metal ions is below 7ppb.Added stem, cup and cement product information.This complaint was updated on: december 22, 2017.Doi: (b)(6) 2007; dor: (b)(6) 2014; right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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.

• Brand Name: ENDURANCE CALCAR SZ3 200MM
• Common Device Name: MISCELLANEOUS HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582
• MDR Report Key: 7159911
• Report Number: 1818910-2018-50089
• Device Sequence Number: 1978976
• Product Code: JDI
• UDI-Device Identifier: 10603295057338
• UDI-Public: 10603295057338
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K961619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/07/2017
• Device Catalogue Number: 152162000
• Device Lot Number: A4KDKA000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 67