MAUDE Adverse Event Report: EXACTECH, INC. ALT CUP CLSTR G3 SZ 48; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	ALT CUP CLSTR G3 SZ 48
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
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: alt xle lnr ntrl g3 32 (cat# 01-030-40-0332 / serial# (b)(4)) alteon 6.5mm screw, 25mm (cat# 180-65-25 / serial# (b)(4) ) additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 9 mos.Postop the initial l tha for this (b)(6) y/o female patient, the surgeon removed alteon cup, liner and bone screw.Cup became loose and the bone screw broke.Revised patient to larger size multi-hole alteon cup and multiple bone screws.Patient was last known to be in stable condition following the event.The device will not be returned for evaluation as devices were thrown away by nurse.
Additional Manufacturer Narrative
After further review of additional information received.(h3) the evaluation noted that revision reported was likely the result of an of osteolysis, subsequent migration and loosening of the acetabular cup and ultimate fracture of the bone screw.However, this cannot be confirmed as the explants are not available for evaluation and additional information was not provided.The most probable root cause associated with the reported event of "loosening - acetabular" is associated with weakened integration of the device 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 CUP CLSTR G3 SZ 48
• 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: 11688767
• Report Number: 1038671-2021-00177
• Device Sequence Number: 14226975
• Product Code: JDI
• UDI-Device Identifier: 10885862549174
• UDI-Public: 10885862549174
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 06/10/2021

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 Model Number: ALT CUP CLSTR G3 SZ 48
• Device Catalogue Number: 01-030-01-0348
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 06/10/2021
• 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: 77 YR