MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US RECLAIM PRX BDY CONE 24X85; RECLAIM IMPLANT : HIP FEMORAL STEM

Model Number	1975-24-085
Medical Device Problem Codes	Difficult to Insert (1316); Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/19/2021
Type of Reportable Event	Malfunction
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
It was reported that intraoperatively both the surgeon and the attending sales rep were not able to fix the reclaim proximal neck segment to the distal stem.Surgery delay about 10 minutes, no adverse patient consequences.Left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned device did not identify any product defects or anomalies.This device was manufactured on 13-feb-2017.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot : 1) quantity manufactured: (b)(4).2) date of manufacture: 13-feb-2017.3) any anomalies or deviations identified in dhr: none.4) expiry date: 31-jan-2027.5) ifu reference: (b)(4).Corrected: h3.
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: RECLAIM PRX BDY CONE 24X85
• Common Device Name: RECLAIM IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12330350
• Report Number: 1818910-2021-17947
• Device Sequence Number: 4713227
• Product Code: LPH
• UDI-Device Identifier: 10603295076926
• UDI-Public: 10603295076926
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1975-24-085
• Device Catalogue Number: 197524085
• Device Lot Number: H44077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 09/07/2021; 10/13/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 09/16/2021; 10/13/2021
• 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: RECLAIM DISTAL TAPERED 16X190; RECLAIM LOCKING BOLT 95MM; RECLAIM PRX BDY CONE 24X85; RECLAIM DISTAL TAPERED 16X190; RECLAIM LOCKING BOLT 95 MM; RECLAIM PRX BDY CONE 24X85