MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM DISTAL TAPERED 20X190A; RECLAIM IMPLANT : HIP FEMORAL STEM

Model Number	1977-20-190
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Hypersensitivity/Allergic reaction (1907); Swelling/ Edema (4577)
Date of Event	08/19/2021
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
Subject id: (b)(6).Study : dots.Clinical adverse event received for mass in rt posterior thigh, hamstring region.Event is not serious and is considered moderate.Event is possibly related to both device and procedure.Date of implant (cup): (b)(6) 2003.Date of implant: (b)(6) 2012.Date of event: (b)(6) 2021.(right hip).Treatment: diagnostic mri.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Provided x-ray images have been reviewed.A root cause for the problems reported cannot be determined.Nothing indicative of a product problem was identified.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.
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 DISTAL TAPERED 20X190A
• Common Device Name: RECLAIM IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12512571
• Report Number: 1818910-2021-20754
• Device Sequence Number: 3687145
• Product Code: LPH
• UDI-Device Identifier: 10603295077275
• UDI-Public: 10603295077275
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2021

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: 1977-20-190
• Device Catalogue Number: 197720190
• Device Lot Number: 157780
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 09/15/2021; 10/18/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 09/27/2021; 10/19/2021
• 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: 12/14 ARTICUL 40MM M SPEC+5; ALTRX +4 NEUT 40IDX58OD; PINN CAN BONE SCREW 6.5MMX30MM; PINN CAN BONE SCREW 6.5MMX35MM; PINNACLE SECTOR II CUP 58MM; RECLAIM DISTAL TAPERED 20X190A; RECLAIM PRX BDY CONE 24X85; 12/14 ARTICUL 40MM M SPEC+5; ALTRX +4 NEUT 40IDX58OD; PINN CAN BONE SCREW 6.5MMX30MM; PINN CAN BONE SCREW 6.5MMX35MM; PINNACLE SECTOR II CUP 58MM; RECLAIM DISTAL TAPERED 20X190A; RECLAIM PRX BDY CONE 24X85
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Weight: 73