MAUDE Adverse Event Report: EXACTECH, INC. ALT XLE LNR NTRL G6 36; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	170-36-93
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	01/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial right tha on (b)(6) 2021.The patient was revised on (b)(6) 2023 due to complaints of pain and recalled poly.The reported event is not related to the breakage of a device and did not lead to surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: (b)(4) 01-030-01-0654 - alt cup clstr g6 sz 54.(b)(4) 01-030-40-0636 - alt xle lnr ntrl g6 36.(b)(4) 164-13-11 - novation element ro s/o col sz 11.
Additional Manufacturer Narrative
H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of pain and the subsequent revision cannot be conclusively determined; however, it is most likely related to patient conditions as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
Correction to b5: it was previously reported that this patient had a recalled poly.This information was incorrect.The patient has an xle poly, which is not part of the recall.
Additional Manufacturer Narrative
H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of pain and the subsequent revision cannot be conclusively determined; however, it is most likely related to patient conditions as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d4, g4, h4, h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The revision was likely the result of acetabular liner prosthesis wear.Wear can be the result of implant placement, patient physical activity, patient health conditions or anatomic challenges, unintentional interaction of the implant with third bodies such as bone or cement fragments, inclusion of the polyethylene in the packaging recall, or any combination of these possibilities.However, the definitive cause of the prosthesis wear cannot be confirmed.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: ALT XLE LNR NTRL G6 36
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16252676
• Report Number: 1038671-2023-00075
• Device Sequence Number: 5273524
• Product Code: LPH
• UDI-Device Identifier: 10885862549655
• UDI-Public: 10885862549655
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K182502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/27/2025

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: 05/23/2026
• Device Model Number: 170-36-93
• Device Catalogue Number: 01-030-40-0636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/10/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 02/06/2023; 02/06/2023; 07/24/2023; 08/22/2025
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 02/22/2023; 04/14/2023; 07/27/2023; 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male