MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM DISTAL TAPERED 18X190; RECLAIM IMPLANT : HIP FEMORAL STEM

Catalog Number	197618190
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	09/28/2018
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
The patient was revised to address loosening of the reclaim stem at the bone to implant interface.
Additional Manufacturer Narrative
(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: RECLAIM DISTAL TAPERED 18X190
• Common Device Name: RECLAIM IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork, munster ; EI
• MDR Report Key: 7985032
• Report Number: 1818910-2018-72976
• Device Sequence Number: 11111495
• Product Code: KWA
• UDI-Device Identifier: 10603295077084
• UDI-Public: 10603295077084
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2018

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: 04/01/2025
• Device Catalogue Number: 197618190
• Device Lot Number: 660564
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 11/13/2018
• 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: 79 YR