MAUDE Adverse Event Report: EXACTECH, INC. ALT HA S CLR EXT SZ 8; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	ALT HA S CLR EXT SZ 8
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: g2 neutral 32mm gxl liner (cat# 130-32-52 / serial# (b)(4)), 32+3.5 cocr head (cat# 142-32-03 / serial# (b)(4)), 20mm 6.5 bone screw (cat# 180-65-20 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately five years post initial left tha, this male patient was brought back for left hip pain.X rays showed signs of potential loosening of the stem.The head was removed.The stem was checked and found to be loose.The stem was removed.Attention taken to the acetabular component.The poly liner was removed with use of a 45mm 6.5 bone screw.The cup was checked and found to be well fixed.A new g2 lipped 36mm xle liner was implanted.A 21x245 stem was implanted with a 36+7 biolox head.There were no parts or pieces fall into the patient wound site.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.X-ray received.The device will be return.
Additional Manufacturer Narrative
After further review of additional information received the following sections device available for evaluation, date rec¿d by mfr, if follow-up, what type, device evaluated by mfr and adverse event problem have been updated accordingly.The revision reported was likely the result of an insufficient bond between the femoral stem and the bone, patient-related conditions, or a combination of the two, which led to aseptic (non-infected) femoral stem loosening.The most probable root cause associated with the reported event of "loosening - femoral stem¿ is associated with weakened integration of the femoral stem at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.

• Brand Name: ALT HA S CLR EXT SZ 8
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, 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: 13922529
• Report Number: 1038671-2022-00283
• Device Sequence Number: 1764406
• Product Code: JWH
• UDI-Device Identifier: 10885862320971
• UDI-Public: 10885862320971
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162732
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 09/01/2022

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: 05/24/2022
• Device Model Number: ALT HA S CLR EXT SZ 8
• Device Catalogue Number: 190-31-08
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 03/26/2022
• Supplement Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male