MAUDE Adverse Event Report: EXACTECH, INC. MCS GXL LINER 5/15 DEG 5052X28; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	MCS GXL LINER 5/15 DEG 5052X28
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Joint Dislocation (2374); Osteolysis (2377); Joint Laxity (4526); Insufficient Information (4580)
Date of Event	03/10/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 1021635 650-00-10 - optecure 10cc rt.1240193 100-28-05 - cocr femoral head 28mm +5mm neck.
Event or Problem Description
Per a report from the legal department, the patient had an initial right hip replacement on (b)(6) 2008.Approximately 6 years and 10 months after the initial procedure the patient had a hip revision on (b)(6) 2015 due to suffering from symptoms associated with excessive wear of the gxl, including, but not limited to instability, pain and lack of mobility.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
H3: based on available information, the revision involved in the case may have been the result of a combination of the risk factors specified in the hhe including but not limited to use error, implant positioning, and/or patient factors.However, this cannot be confirmed as the devices, radiographs, photographs, and operative notes were not provided.
Additional Manufacturer Narrative
Investigation results - based on available information, the revision was likely the result of a combination of the risk factors specified in hhe2020-09-11-02 including but not limited to significant edge loading of the femoral head on the acetabular liner, implant positioning, and patient factors, which led to wear of the acetabular liner and proximal migration of the femoral head.Initial submission: all fields in section f should be blank, this is an manufacturer's report.
Event or Problem Description
Additional information received: revision operative report of (b)(6) 2015- postoperative diagnosis: failed right total hip arthroplasty with extensive polyethylene wear, and massive pelvic osteolysis.Procedure: patient presented with acute dislocation which was related to hip instability from polyethylene wear.There was a significant eccentricity of the polyethylene with risk for wear through.In the joint, there was a small amount of synovial fluid and a large amount of synovitis and changes from her osteolysis.The socket was well fixed and in quite good position.Confirm eccentric wear of the socket with significant superior wear; based on the inscription on the rim that the liner was indeed gxl xlinked polyethylene - removal of the socket.There is posterior wall deficiency and with the plate is exposed posteriorly, there are a very large cystic osteolytic defects in the ischial tuberosity as well as the ileum.There was no discontinuity and there was massive bone loss.Identified 3 screws that were impinging on the socket, removed this from around the pelvis and the plate; prominent to the socket but this could not be removed without significant destruction of the remaining posterior wall; this was left.Removed 52 mm socket.The remainder of the socket had bone defects from the osteolysis.Placed the bone graft, finger packing into the defects and reverse reamed them sequentially until all were filled.Devices were trialed and then implanted.Bulky dressing was applied, and the patient is transferred to the recovery room in stable condition, after reversal of anesthesia, no complications.There is no other information available.

• Brand Name: MCS GXL LINER 5/15 DEG 5052X28
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 3523771140
• MDR Report Key: 16775699
• Report Number: 1038671-2023-00760
• Device Sequence Number: 20549993
• Product Code: JDI
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/16/2026

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: 02/06/2011
• Device Model Number: MCS GXL LINER 5/15 DEG 5052X28
• Device Catalogue Number: 104-28-44
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 08/14/2023; 12/11/2023; 09/16/2026
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 09/11/2023; 12/12/2023; 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2007
• 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: A
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1728-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female