MAUDE Adverse Event Report: EXACTECH, INC. BIOLOX DELTA OPTION FEMORAL HEAD 40MM OD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Catalog Number	170-40-50
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10.Concomitants: 7249154.170-50-07 - biolox delta adapter 16/18-12/14; +7mm.
Event or Problem Description
As reported via legal documentation, a patient had right hip revision surgery on (b)(6)2022.They subsequently had a second right hip revision on (b)(6) 2022, approximately 2 months after their preceding revision.(b)(6) 2022 op report postoperative diagnosis: dislocation of internal right hip prosthesis.The surgeon noted there was a small effusion.Inspection of the abductors did show delamination from the greater trochanter approximately 75% with a split tear.The femoral head was dislocated.The surgeon further noted that the ring was mobile and the implant was well fixed to the cup.The patient was transferred to the recovery room in stable condition; there were 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 additional information is available.
Additional Manufacturer Narrative
Investigation results-the cause of the patient¿s instability, prosthesis dislocation, and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.The patient has bilateral hip replacements.The revision operative report had no mention of device malfunction or wear.These devices are used for treatment not diagnosis.There is no other information available.

• Brand Name: BIOLOX DELTA OPTION FEMORAL HEAD 40MM OD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• 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: michael crader ; 3523782617
• MDR Report Key: 17458077
• Report Number: 1038671-2023-01859
• Device Sequence Number: 2904759
• Product Code: LZO
• UDI-Device Identifier: 10885862155580
• UDI-Public: 10885862155580
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2024

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?: No
• Device Expiration Date: 03/07/2026
• Device Catalogue Number: 170-40-50
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2023
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female