MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	136-36-53
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Aseptic loosening (4883)
Date of Event	12/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 188-01-09 - wedge plasma x/o sz 9.(b)(6), 170-36-07 - biolox delta femoral head 36mm od, +7mm.(b)(6), 180-65-45 - alteon 6.5mm screw, 45mm.(b)(6), 180-65-30 - alteon 6.5mm screw, 30mm.(b)(6), 180-65-30 - alteon 6.5mm screw, 30mm.(b)(6), 186-01-58 - integrip cc, cluster 58mm, g3.
Event or Problem Description
Per a report from the legal department a 56 y/o male patient had a left hip replacement on (b)(6) 2015.Approximately 7 years after the initial procedure the patient had a left hip revision on (b)(6) 2022 due to severe pain.Revision op report ((b)(6) 2022).Diagnosis: failed left hip replacement (grossly loose cup).Very stable reconstruction.Femmoral stem was stable and well fixed - therefore they didn't need to be revised.The cup was grossly loose and removed easily - there was moderate amount of osteolysis surrounding the acetabular implant.Moderate amount of osteolysis changes to the soft tissue as a result of poly wear.Patient was reversed from anesthesia and sent to pacu in stable condition.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 additional information is available.
Additional Manufacturer Narrative
Added information to d7a.H3: investigation results - the revision reported may have been the result of prosthesis wear, osteolysis, and acetabular cup loosening as reported in the operative notes.The prosthesis wear may have been the result of the orientation of the acetabular cup, edge loading/impingement, patient-related conditions, or any combination of these possibilities.The aseptic (non-infected) acetabular loosening may have been the result of an insufficient bond between the acetabular cup and the bone.Additional contributing factors to the reported failures may have been the result of a combination of risk factors including but not limited to being implanted with a component having a shelf age of greater than 2 years.However, this cannot be confirmed as the devices were not available for evaluation, and images and radiographs were not provided at the time of this evaluation.
Event or Problem Description
It was reported that the patient underwent an initial left total hip arthroplasty.Subsequently, it was reported that the patient experienced pain, osteolysis, prosthesis wear and acetabular loosening.As a result, the patient underwent a left hip revision approximately 7 years after initial implantation.Patient was last known to be in stable condition.No further information available.

• Brand Name: NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS
• 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: julia goldberg ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16832391
• Report Number: 1038671-2023-00856
• Device Sequence Number: 16626750
• Product Code: JDI
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• 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): 09/25/2026

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: 08/22/2020
• Device Model Number: 136-36-53
• Device Catalogue Number: 136-36-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2023
• Supplement Date Received by Manufacturer: 11/22/2023; 09/25/2026
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 12/14/2023; 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2015
• 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-1729-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male