MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM PRX BDY CONE 20X85; RECLAIM IMPLANT : HIP FEMORAL STEM

Model Number	1975-20-085
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
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 patient was also operated on on (b)(6) 2017.An der was reported at that time patient has history of recurrent infection and severe psoriatic arthritis.Patient presents with pain and xrays revealing visible gas in xrays, leading surgeon to believe patient is infected.All components except the cup were removed.Surgeon felt that if the cup were removed, there was not enough bone to place another shell into.A thorough debridement and subsequent irrigation was performed.A new set up was utilized to reimplant the patient along with placement of antibiotic beads.Surgeon also coated exposed implants with high dose antibiotic cement.Doi: (b)(6) 2017 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.Corrected: g1.

• Brand Name: RECLAIM PRX BDY CONE 20X85
• Common Device Name: RECLAIM IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11938984
• Report Number: 1818910-2021-11884
• Device Sequence Number: 4225954
• Product Code: KWA
• UDI-Device Identifier: 10603295076889
• UDI-Public: 10603295076889
• 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: 2017
• 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): 05/19/2021

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: 1975-20-085
• Device Catalogue Number: 197520085
• Device Lot Number: H43693
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 06/30/2021
• 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: DLT TS CER HD 12/14 28MM +1.5; PINN LNR CON +4 10D 28IDX50OD; PINN MULTIHOLE W/GRIPTION 50MM; RECLAIM DISTAL TAPERED 14X190A; RECLAIM PRX BDY CONE 20X85; DLT TS CER HD 12/14 28MM +1.5; PINN LNR CON +4 10D 28IDX50OD; PINN MULTIHOLE W/GRIPTION 50MM; RECLAIM DISTAL TAPERED 14X190A; RECLAIM PRX BDY CONE 20X85
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR