MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM DISTAL TAPERED 14X140; HIP IMPLANT

Catalog Number	197614140
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	11/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Der states that the patient had revision hip using depuy reclaim revision inspection of stem.It was revealed that proximal end of stem was machined incorrectly and in a way that it prevented the proximal body from fitting.This was confirmed after comparing implant in question to another implant.Doe: (b)(6) 2017; right hip; surgical delay of 1 1/2 hours.
Additional Manufacturer Narrative
(b)(4).Investigation summary examination the returned component finds no evidence of any manufacturing error.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.Device history lot 741084 device history review no deviations or anomalies identified.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: RECLAIM DISTAL TAPERED 14X140
• Common Device Name: HIP IMPLANT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• MDR Report Key: 7118443
• Report Number: 1818910-2017-51517
• Device Sequence Number: 13742169
• Product Code: KWA
• UDI-Device Identifier: 10603295076995
• UDI-Public: 10603295076995
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K102080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2017

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: No Information
• Device Catalogue Number: 197614140
• Device Lot Number: 741084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR