MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM PRX BDY CONE 24X105; RECLAIM IMPLANT : HIP FEMORAL STEM

Catalog Number	197524105
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/12/2018
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.Concomitant medical products: dlt ts cer hd 12/14 36mm +5.0 hip femoral head; unknown hip acetabular liner; unknown hip acetabular cup; reclaim distal tapered 21x140 hip femoral stem; reclaim prx bdy cone 24x105 hip femoral body.Represents surgical intervention.
Event or Problem Description
Revision total hip replacement performed post peri prosthetic fracture.Reclaim stem removed and long reclaim stem inserted.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.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 PRX BDY CONE 24X105
• Common Device Name: RECLAIM IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7942387
• Report Number: 1818910-2018-71587
• Device Sequence Number: 856644
• Product Code: KWA
• UDI-Device Identifier: 10603295076940
• UDI-Public: 10603295076940
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K102080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2018

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 Catalogue Number: 197524105
• Device Lot Number: 633084
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 10/19/2018
• 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