MAUDE Adverse Event Report: EXACTECH, INC. INTEGRIP MH CUP SZ 68MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	186-03-68
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Implant Pain (4561); Insufficient Information (4580)
Date of Event	03/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported post-op via clinical study that the 73 yo male experienced acetabular component loosening, resulting in aseptic loosening acetabulum of left hip.The patient was revised on (b)(6) 2019.The outcome was last known as resolved on (b)(6) 2019.
Additional Manufacturer Narrative
D10.Concomitants: serial #: unassigned, category #: 32135-38h - flex drill m 3.2x38 hd lenkbar; serial #: unassigned, category #: 32135-52h - flex drill m 3.2x52 hd lenkbar; serial #: (b)(4), category #: 186-05-11 - integrip augment g5 x 11mm cemented; serial #: (b)(4), category #: sc45-40 - bone screw 4.5mm dia x 40mm lng; serial #: (b)(4), category #: sc45-45 - bone screw 4.5mm dia x 45mm lng; serial #: (b)(4), category #: sc45-25 - bone screw 4.5mm dia x 25mm lng; serial #: (b)(4), category #: 180-65-30 - alteon 6.5mm screw, 30mm; serial #: (b)(4), category #: 140-36-55 - nv ehxl ntrl lnr g5 36mm; serial #: (b)(4), category #: 180-65-20 - alteon 6.5mm screw, 20mm; serial #: (b)(4), category #: 180-65-30 - alteon 6.5mm screw, 30mm; serial #: (b)(4), category #: 180-65-20 - alteon 6.5mm screw, 20mm; serial #: (b)(4), category #: 180-65-20 - alteon 6.5mm screw, 20mm.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: h6 - type of investigation, investigation findings and investigation conclusions, h11 the following sections were corrected: b1, b2, b5, d1, d2a, d2b, d6a, g1, g2, h3, h6 - health effect - clinical code, medical device problem code and component code the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A review of manufacturing data was performed and identified a non-conforming product report was issued during manufacturing due to an undersized hole dimension.All affected pieces were removed from the lot and reworked.All other pieces in the lot were accepted with conformance to the device requirements.There were no other complaints discovered from this acetabular cup's manufacturing lot of 8 units.As a result, it is not considered that this would have had any impact on the reported event.A review of the manufacturing nonconformance database for the related bone screw manufacturing lots was conducted.There were non-conformance reports identified for two of the lots issued due to damage to the screw threads.All affected pieces were removed from the lot and scrapped.No other complaints were discovered for the screw lots in question.As a result, it is not considered that this would have had any impact on the reported event.A review of complaint history determined that no further action is required as no trends were identified.The reason for the revision reported cannot be confirmed from the information provided but may be the result of acetabular loosening.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that the patient underwent a left hip revision surgery.Subsequently, the patient experienced loosening of the acetabular cup.As a result, the patient underwent another left hip revision surgery approximately one week after initial implantation.No further patient impact reported.No further information available.

• Brand Name: INTEGRIP MH CUP SZ 68MM
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 16770980
• Report Number: 1038671-2023-00753
• Device Sequence Number: 11548268
• Product Code: LPH
• UDI-Device Identifier: 10885862244437
• UDI-Public: 10885862244437
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122798
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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: 12/28/2024
• Device Catalogue Number: 186-03-68
• 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: 03/07/2023
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2015
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White