MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM DISTAL TAPERED 14X190A; RECLAIM IMPLANT : HIP FEMORAL STEM

Model Number	1977-14-190
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/02/2021
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 the patient presented with an infection.The patient went through several i&ds and would not get better.The surgeon decided to do a hip disarticulation.The stem, liner and cup had to come out.There were no instruments broken or damaged.All components were removed.Doi: (b)(6) 2021 - dor: (b)(6) 2021 (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.Device history lot the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: RECLAIM DISTAL TAPERED 14X190A
• Common Device Name: RECLAIM IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12517272
• Report Number: 1818910-2021-20852
• Device Sequence Number: 14786901
• Product Code: LPH
• UDI-Device Identifier: 10603295077152
• UDI-Public: 10603295077152
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2021

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: 1977-14-190
• Device Catalogue Number: 197714190
• Device Lot Number: 225887
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 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: DELTA CER HEAD 12/14 28MM +1.5.; LPS PROX FEM STD BODY NEUTRAL.; LPS SEGMENTAL COMPONENT 105MM.; PINN LNR CON +4 10D 28IDX50OD.; PINN MULTIHOLE W/GRIPTION 50MM.; RECLAIM DISTAL TAPERED 14X190A.; DELTA CER HEAD 12/14 28MM +1.5.; LPS PROX FEM STD BODY NEUTRAL.; LPS SEGMENTAL COMPONENT 105MM.; PINN LNR CON +4 10D 28IDX50OD.; PINN MULTIHOLE W/GRIPTION 50MM.; RECLAIM DISTAL TAPERED 14X190A.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR