MAUDE Adverse Event Report: EXACTECH, INC. WEDGE PLASMA X/O SZ 4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	WEDGE PLASMA X/O SZ 4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products - biolox delta femoral head 32mm od, +3.5mm (cat# 170-32-03 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 3 months postop the initial rtha, this (b)(6) y/o female patient experienced a peri prosthetic fracture, and was revised to monobloc stem.The patient was last known to be in stable condition following the event.The device will not be returned for evaluation due to facility policy.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g7, h2, h3 and h6 have been updated accordingly.As reported, approximately 3 months postop the initial rtha, this 53 y/o female patient experienced a peri prosthetic fracture and was revised to monobloc stem.The patient was last known to be in stable condition following the event.The device will not be returned for evaluation due to facility policy.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design, manufacturing, or patient related issues.The cause of the bone fracture cannot be conclusively determined; however, it is most likely is related to the patient¿s underlying condition.

• Brand Name: WEDGE PLASMA X/O SZ 4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11992550
• Report Number: 1038671-2021-00296
• Device Sequence Number: 14535167
• Product Code: JDI
• UDI-Device Identifier: 10885862250933
• UDI-Public: 10885862250933
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K140674
• 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,Followup
• Report Date (Section B): 07/08/2021

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 Expiration Date: 07/16/2019
• Device Model Number: WEDGE PLASMA X/O SZ 4
• Device Catalogue Number: 188-01-04
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 07/08/2021
• 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
• Patient Age: 53 YR