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

Model Number	1975-24-075
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Date of Event	06/01/2020
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 patient being revised for suspected loose reclaim stem.After disassembling the stem in surgery, the proximal body was removed from the distal stem.The distal stem was found to be well fixed and not loose.It was discovered that the patient had a proximal femur fracture, unsure if it was caused iatrogenically or if it was already there.Decision was made my surgeon to leave previous reclaim distal stem and implant a new proximal body of a different size even after the rep advised agaist this ans stated it was off label use.Liner and head were also removed and replaced.No further patient information available doi: 2012, dor: (b)(6) 2020, affected side: left hip.
Additional Manufacturer Narrative
Product complaint (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.

• 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: 10154233
• Report Number: 1818910-2020-13778
• Device Sequence Number: 2027994
• Product Code: KWA
• UDI-Device Identifier: 10603295076919
• UDI-Public: 10603295076919
• 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 Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2020

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 Model Number: 1975-24-075
• Device Catalogue Number: 197524075
• Device Lot Number: 196700
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALTRX +4 NEUT 36IDX58OD; DELTA CER HEAD 12/14 36MM +8.5; RECLAIM PRX BDY CONE 24X75; UNKNOWN HIP FEMORAL STEM (DISTAL STEM); ALTRX +4 NEUT 36IDX58OD; DELTA CER HEAD 12/14 36MM +8.5; RECLAIM PRX BDY CONE 24X75; UNKNOWN HIP FEMORAL STEM (DISTAL STEM)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR