MAUDE Adverse Event Report: EXACTECH, INC. ALT HA S CLR STD SZ 5; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS

Model Number	190-30-05
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561); Aseptic loosening (4883)
Date of Event	07/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, this female patient had a right side tha on (b)(6) 2017.The patient was brought back for right hip pain.The hip was dislocated, the femoral head removed.The stem was checked, found to be loose and removed.Attention turned to cup.The liner was removed with the use of a bone screw.The cup was checked, found to be well fixed.A new g1 32 lip xle liner was implanted.Attention turned back to the femur where a new size 6 std offset hps stem was cemented in place along with a new 32 +3.5 biolox head.There is no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.The devices are not returning as the patient requested them.
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical products: 130-32-51 nv gxl liner neutral, 32mm id group 1 cups - 4120690; 170-32-03 biolox delta femoral head 32mm od, +3.5mm- 4320796.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of an insufficient bond between the femoral stem and the bone, an under sized femoral stem for the patient¿s anatomy/femoral bone, patient related conditions, or a combination of these possibilities, which led to aseptic (non-infected) femoral stem loosening and pain.However, this cannot be confirmed as the devices were not available for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d8, f10 (remove information erroneously added on initial report), h6 - health effect - clinical code, component code, type of investigation, investigation findings, investigation conclusion and h11.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.A definitive root cause was unable to be determined; however, may have resulted from an insufficient bond between the femoral stem and the bone, an under sized femoral stem for the patient¿s anatomy/femoral bone, patient related conditions, or a combination of these possibilities, which led to aseptic (non-infected) femoral stem loosening and pain.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: ALT HA S CLR STD SZ 5
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS
• 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15174811
• Report Number: 1038671-2022-00886
• Device Sequence Number: 5121748
• Product Code: MEH
• UDI-Device Identifier: 10885862321077
• UDI-Public: 10885862321077
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162732
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2026

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: 05/17/2022
• Device Model Number: 190-30-05
• Device Catalogue Number: 190-30-05
• 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: 07/21/2022
• Supplement Date Received by Manufacturer: 06/13/2023; 04/14/2026
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 06/27/2023; 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2017
• 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: Hospitalization; Required Intervention
• Patient Sex: Female