MAUDE Adverse Event Report: DEPUY IRELAND 9616671 RECLAIM PRX BDY CONE 20X85; RECLAIM IMPLANT : HIP FEMORAL STEM

Catalog Number	197520085
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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 subsidence of the reclaim stem.It was also reported that the patient wanted to be longer on operative side.Doi: (b)(6) 2017; dor: (b)(6) 2018; right hip.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.

• Brand Name: RECLAIM PRX BDY CONE 20X85
• Common Device Name: RECLAIM IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7670265
• Report Number: 1818910-2018-63965
• Device Sequence Number: 2643690
• Product Code: KWA
• UDI-Device Identifier: 10603295076889
• UDI-Public: 10603295076889
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K102080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 06/12/2018

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: 197520085
• Device Lot Number: H50952
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 08/08/2018
• 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