MAUDE Adverse Event Report: EXACTECH, INC. MONO REV STEM STD 16X245; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER

Model Number	MONO REV STEM STD 16X245
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: nv ehxl alip lnr g1 32mm (cat# 142-32-61 / serial# (b)(4)).Biolox delta femoral head 32mm od, -3.5mm (cat# 170-32-93 / serial# (b)(4)).The evaluation noted that revision reported was likely the result of either undersizing the femoral stem for the patient¿s anatomy/femoral bone or insufficient bony support for the implant.However, this cannot be confirmed as the devices were not returned for evaluation and no additional information was provided.The most probable root cause associated with the reported event of "femoral stem subsidence" is associated with a femoral stem that subsides into the prepared femoral canal further than expected.This can occur during implantation or post-operatively.
Event or Problem Description
As reported, approximately 3 months postop the initial r tha this female patient was brought to surgery for a subsided 16x245 monobloc stem.The r hip was dislocated, the femoral head and the stem were removed, the acetabular component was exposed, and the poly liner was removed.The patient received a new g1 xle extended coverage liner, the femur was reamed up to a 19x245 stem and a new 19x245 stem was implanted.The new 32 +7 biolox head was implanted.Patient was last known to be in stable condition following the event.The device will not be returned for evaluation as the implants were discarded by hospital.

• Brand Name: MONO REV STEM STD 16X245
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11702069
• Report Number: 1038671-2021-00183
• Device Sequence Number: 3535529
• Product Code: JDI
• UDI-Device Identifier: 10885862282101
• UDI-Public: 10885862282101
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/21/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/09/2021
• Device Model Number: MONO REV STEM STD 16X245
• Device Catalogue Number: 01-010-16-4245
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability