MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM PRX BDY CONE 24X85; RECLAIM IMPLANT : HIP FEMORAL STEM

Model Number	1975-24-085
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Fall (1848); Limb Fracture (4518)
Date of Event	04/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision of a reclaim stem as the implant fractured.The patient had a miss-step while walking which caused her to stumble.The implant then fractured.See attached photo.As a result of the stem fracturing, this caused the proximal femur to fracture.This distal part of the stem was extremely well fixed and was very difficult to remove.The proximal part of the stem and body was easy to remove as this part of the femur was fractured causing it to become loose.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Available xray evidence was reviewed.Based in attached evidence, it cannot be determinate that device was used in a manner for which it is not labeled, intended or recommended by depuy.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: RECLAIM PRX BDY CONE 24X85
• Common Device Name: RECLAIM IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14251795
• Report Number: 1818910-2022-07890
• Device Sequence Number: 5015345
• Product Code: LPH
• UDI-Device Identifier: 10603295076926
• UDI-Public: 10603295076926
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2022

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: 1975-24-085
• Device Catalogue Number: 197524085
• Device Lot Number: J2359M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CERCL-CABLE W/CRIMP Ø1.7 SST.; CERCL-CABLE W/CRIMP Ø1.7 SST.; COMPETITOR LIMA CUP.; COMPETITOR LIMA HEAD.; DLT TS CER HD 12/14 40MM +1.5.; LCP PROXFEM HOOKPL 4.5/5 SHAFT 4HO L169.; LOCKSCR Ø5 SELF-TAP L14 SST.; LOCKSCR Ø5 SELF-TAP L14 SST.; LOCKSCR Ø5 SELF-TAP L18 SST.; POSITION-PIN 4.5 F/LCP SST.; POSITION-PIN 4.5 F/LCP SST.; RECLAIM DISTAL TAPERED 15X190A.; RECLAIM PRX BDY CONE 24X85.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female