MAUDE Adverse Event Report: EXACTECH, INC. ALT HA S CLR EXT SZ 7; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	ALT HA S CLR EXT SZ 7
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, the (b)(6) male patient had a revision due to stem subsidence.Patient was revised with a zb stem, cup was retained and a new liner was implanted.There was no breakage of a device.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Photos and x-rays received.Product will not be returned.
Additional Manufacturer Narrative
After further review of additional information received the following sections d4, d6a, d10, g3, g6, h2, h3, h4 and h6 have been updated accordingly.Section d10: concomitant products: nv gxl lnr, +5lat, 36mm g3-56/58mm cups (cat# 136-36-53 / serial# (b)(6)).(h3) the revision reported may have been the result of either under sizing the femoral stem for the patient¿s anatomy/femoral bone and/or insufficient bony support for the implant, possibly due to a patient-related condition, which led to femoral stem subsidence.However, this cannot be confirmed as immediate post-operative x-rays of the index surgery were unable to be obtained.Therefore, a change in the position of the femoral stem from initial implantation cannot be confirmed.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.

• Brand Name: ALT HA S CLR EXT SZ 7
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 14519116
• Report Number: 1038671-2022-00616
• Device Sequence Number: 5604109
• Product Code: JDI
• UDI-Device Identifier: 10885862320964
• UDI-Public: 10885862320964
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K162732
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2022

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: 12/27/2022
• Device Model Number: ALT HA S CLR EXT SZ 7
• Device Catalogue Number: 190-31-07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2022
• Supplement Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.2MM DRILL BIT 20MM 1PK; ALTEON 6.5MM SCREW, 20MM (2); BIOLOX DELTA FEMORAL HEAD 36MM OD, +0MM; BIOLOX DELTA FEMORAL HEAD 36MM OD, -3.5MM; INTEGRIP CC, CLUSTER 58MM, G3
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male