MAUDE Adverse Event Report: EXACTECH, INC. MCS GXL LINER 5/15 DEG 5052X28; SEE H10

Catalog Number	104-28-44
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	04/06/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had a revision of right hip arthroplasty from another device for: status post right tha performed approx.14 years ago, it was found that there was a cyst of the superior aspect of the acetabulum.However, the acetabular component was found to be rigid in its fixation.Osteolytic lesion on superior aspect of acetabulum.The patient was revised to an exactech hip device on (b)(6) 2008 and then approximately 7 years, 9 months later experienced a second revision.On (b)(6) 2016 the patient was revised to an exactech cocr femoral head 36mm, and the poly liner and acetabular component of a competitor.Revision operative report of (b)(6) 2016- postoperative diagnosis-failed tha with massive osteolysis both retroacetabular and proximal femoral.Significant amount of osteolysis around acetabulum.Had polyethylene wear and underwent a head liner exchange in 2008.Had early wear of this polyethylene liner such that it created significant osteolysis behind his acetabulum and in his proximal femur.Procedure: there were signs of significant polyethylene debris.Debridement of proximal femoral osteolysis.Significant amount of osteolysis around the acetabulum and acetabular component.Devices were trailed and then implanted.A dressing was applied, and the patient was placed in an abduction pillow.No complications.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No other information is available.
Additional Manufacturer Narrative
D2b.Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented.D10.Concomitants: (b)(6)- 100-28-00 - cocr femoral head 28mm +0mm neck, (b)(6)- 606-01-10 - opteform rt allograft -10cc, (b)(6)- 650-00-10 - optecure 10cc rt, (b)(6)- 650-00-10 - optecure 10cc rt, these devices are used for treatment not diagnosis.Pending investigation.There is no other information available.
Additional Manufacturer Narrative
H10.H6.Investigation results- the revision reported in (b)(4)was most likely the result of prosthesis wear and osteolysis approximately 21 years after the initial surgery and 7 years after a revision procedure to replace the original acetabular liner and inject bone graft on the acetabular side.Possible contributing factors to the wear and osteolysis include patient-related conditions secondary to age, previous history of osteolysis, and edge-loading.However, the wear and osteolysis cannot be confirmed as the devices were not available for evaluation and no pictures or radiographs were provided at the time of this evaluation.There is no other information available.

• Brand Name: MCS GXL LINER 5/15 DEG 5052X28
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17855684
• Report Number: 1038671-2023-02428
• Device Sequence Number: 3453436
• Product Code: LPH
• 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: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2026

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: 02/26/2011
• 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: 09/07/2023
• Supplement Date Received by Manufacturer: 11/17/2023; 10/01/2026
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 11/30/2023; 10/01/2026
• 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: Initial
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male