MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM PRX BDY CONE 20X75; RECLAIM IMPLANT : HIP FEMORAL STEM

Catalog Number	197520075
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, 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.
Event or Problem Description
Explantation of a reclaim hip-stem left side because of infection.
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.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information was received and stated that the removal was due to the nail cut-out from the femoral neck with secondary reposition loss.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Bfarm dhr review: product description: reclaim prx bdy cone 20x75; product code: 197520075; lot number: m4172z.1) quantity manufactured: (b)(4); 2) date of manufacture: 11-07-2023; 3) any anomalies or deviations identified in dhr: no; 4) expiry date: 30-06-2033; 5) ifu reference: 090200799.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: bfarm dhr review; product description: reclaim prx bdy cone 20x75; product code: 197520075; lot number: m4172z.1) quantity manufactured: (b)(4); 2) date of manufacture: 11-07-2023; 3) any anomalies or deviations identified in dhr: no; 4) expiry date: 30-06-2033; 5) ifu reference: 090200799.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : explantation of a reclaim hip-stem left side because of infection.According to the information received, ¿explantation of a reclaim hip-stem left side because of infection.¿ the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that reclaim prx bdy cone 20x75 found nothing indicative of a device nonconformance or defects that could have contributed to the reported event.A dimensional inspection for the reclaim prx bdy cone 20x75 was not performed since it was not applicable to the complaint condition.The overall complaint was not confirmed as the observed condition of the reclaim prx bdy cone 20x75 would not contribute to the a device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : bfarm dhr review product description: reclaim prx bdy cone 20x75, product code: 197520075, lot number: m4172z.1) quantity manufactured: (b)(4), 2) date of manufacture: 11-07-2023, 3) any anomalies or deviations identified in dhr: no, 4) expiry date: 30-06-2033, 5) ifu reference: 090200799.
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 20X75
• Common Device Name: RECLAIM IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18372077
• Report Number: 1818910-2023-25853
• Device Sequence Number: 18037101
• Product Code: LZO
• UDI-Device Identifier: 10603295076872
• UDI-Public: 10603295076872
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K102080
• 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,Followup,Followup,Followup
• Report Date (Section B): 12/21/2023

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: 197520075
• Device Lot Number: M4172Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 01/02/2024; 01/12/2024; 02/06/2024; 02/14/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 01/10/2024; 01/14/2024; 02/07/2024; 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2023
• 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: COMPETITOR CUP.; DELTA CER HEAD 12/14 32MM +5.; RECLAIM PRX BDY CONE 20X75.; UNKNOWN HIP ACETABULAR CUP.; UNKNOWN HIP ACETABULAR LINERS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female