MAUDE Adverse Event Report: DEPUY IRELAND 9616671 RECLAIM PRX BDY CONE 24X75; RECLAIM IMPLANT : HIP FEMORAL STEM

Catalog Number	197524075
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Migration (4003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Not Applicable (3189)
Date of Event	07/03/2018
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
It was reported that the reclaim stem appeared to be drastically undersized and it rotated into a highly anteverted position within the proximal femur.It was also stated that the stem was loose at bone to implant interface.Doi: unknown; dor: (b)(6) 2018; left hip.
Additional Manufacturer Narrative
Product complaint # :(b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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.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 PRX BDY CONE 24X75
• Common Device Name: RECLAIM IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 7731028
• Report Number: 1818910-2018-65404
• Device Sequence Number: 1365353
• Product Code: KWA
• UDI-Device Identifier: 10603295076919
• UDI-Public: 10603295076919
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/03/2018

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: 197524075
• Device Lot Number: HF9151
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 08/28/2018
• 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: 45 YR