MAUDE Adverse Event Report: EXACTECH, INC. MCS GXL LINER 5/15 DEG 5458X32; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	104-32-45
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	08/31/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that on (b)(6) 2019 the patient was revised to exactech devices and then approximately 13 months later was revised a second time on (b)(6) 2020.Patient revised to competitor devices.On (b)(6) 2020, as patient was putting on his shoes, he felt a "snap" in his right groin, followed by significant pain.On (b)(6) 2020, he experienced three more "snaps" and more pain at his right groin.On (b)(6) 2020, patient presented to doctor with complaints of right hip pain.After a physical examination, doctor recommended he walk with a cane in his left hand "full time," and he scheduled him for a follow up visit.On (b)(6) 2020, patient returned to doctor with complaints of continuing right hip pain and difficulty walking.In his medical records for that date under "impression" doctor documented the following: the x-ray shows substantial polyethylene wear.This hip is either subluxating or he has a fractured hip liner.Plan to revise the entire acetabular component.The femoral head will be reviewed.Doctor stated that they would encounter heterotopic bone.The plan was to use perioperative aspirin to help prevent new bone formation.Further, under "treatment plan" doctor wrote: revision right acetabular component.He understands the difficulty of the surgery.In stance potential for infection, nerve injury, bleeding, transfusion, component failure.He has a failing acetabular component with either subluxation or fracture of the polyethylene component.This needs to be urgently revised.Patient presented for the recommended surgery on (b)(6) 2020.In his operative report of the same date, doctor documented: the previous incision was re-incised, taken down through adipose tissue.There was a synovitis and bursitis with fibrinous particulate matter as well as larger fragments of polyethylene.The short external rotators, retro-trochanteric soft tissue was down and a l-shape capsulorrhaphy was performed from the superior aspect of the femoral head extending up above the acetabulum and down into the neck cut of the femur.Hypertrophic polyethylene-induced synovium was removed in its entirety posterior and superior, and then there was heterotopic ossification starting lateral in the acetabulum, grade 3 in nature and this was carefully dissected from the medial fascia of the abductor and removed.The polyethylene liner was removed., the acetabulum was removed with minimal bone loss.Reaming was with a 57, 58, and 59 and then the activated macrophage polyethylene-induced fibrous material was removed, and this was quite extensive posterior and somewhat superior and then approximately 50 cc of cancellous bone graft was placed in the defect, impacted with the 57 and 59 mm trials, and then a reverse reaming of the 59 reamer.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
H10.D10.Concomitant: sn (b)(6), cat# 100-32-95 - cocr femoral head 32mm -5mm neck.These devices are used for treatment not diagnosis.There is no other information available.Pending investigation.
Additional Manufacturer Narrative
H6: investigation results - the revision reported may have been the result of prosthesis wear due to a combination of the risk factors.Contributing factors to the reported subluxation and/or prosthesis fracture may have been instability and/or implant positioning.However, this cannot be confirmed because the component was not returned for evaluation and radiographs were not provided.

• Brand Name: MCS GXL LINER 5/15 DEG 5458X32
• 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 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson
• MDR Report Key: 18091213
• Report Number: 1038671-2023-02716
• Device Sequence Number: 17823996
• Product Code: LPH
• UDI-Device Identifier: 10885862013606
• UDI-Public: 10885862013606
• 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: 2019
• Device Explanted Year: 2020
• 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
• Report Date (Section B): 11/21/2023

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: 12/15/2019
• Device Catalogue Number: 104-32-45
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male