MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC FLAT CUT TALAR DOME SZ 4 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33680034
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Fracture (1260); Loss of Osseointegration (2408); Migration (4003)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924); Inadequate Osseointegration (2646)
Date of Event	12/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.H3 other text : device disposition unknown.
Event or Problem Description
It was reported that the patient presented for a 1 year follow up.Upon review of the case the physician noticed that the posterior peg of the talar component is broken and is not fully seated upon implantation.The patient underwent a revision procedure.
Event or Problem Description
It was reported that the patient presented for a 1 year follow up.Upon review of the case the physician noticed that the posterior peg of the talar component is broken and is not fully seated upon implantation.No further information is available.
Additional Manufacturer Narrative
Correction - b5, d6a, device code 3, clinical signs code, health impact code.The reported event could be confirmed, based on available medical record and medical expert assessment.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Upon further investigation of the ct scans by healthcare professionals the following was observed ¿the talar component showed increasing radiolucence and some smaller cysts around the implant.In the x-ray of (b)(6) there is breakage/fracture of the posterior peg visible.The implant is loosened and at least a little migration has taken place as otherwise the peg would not have been broken.The preoperative mri scan shows bone bruise and alteration of the bone stock specifically in the area of the former talar fracture following the work accident in 2017.There was at least some bone damage/ e.G.Inflammation visible which may have contributed to a small extent to the loosening of the implant- it could be said here, that, despite these changes, the event is thus falling into the responsibility of the treating surgeon (in addition to the bone condition that favored implant failure(patient related)).Overall, however, the post-traumatic bone and joint damage that can be demonstrated throughout will have led to persistent pain, which had to be remedied by a surgical measure (joint replacement in this case).¿ based on the investigation, the root cause was attributed to the patient related issue.The failure was detected due to some radiolucency and smaller cysts around the talar component.According to the assessment by the hcp, the mri scan shows poor bone quality and the implant is loosened and little migration has taken place which resulted in the breakage of the posterior peg of the talar component as the implant did not connect completely to the bone.Overall, the post-traumatic bone and joint damage would have led to persistent pain which can be remedied by a joint replacement.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: FLAT CUT TALAR DOME SZ 4 INFINITY ADAPTIS
• Common Device Name: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18537720
• Report Number: 3010667733-2024-00026
• Device Sequence Number: 7698591
• Product Code: HSN
• UDI-Device Identifier: 00889797073080
• UDI-Public: 00889797073080
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 33680034
• Device Lot Number: 1729475
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2022
• 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: 54 YR
• Patient Sex: Unknown
• Patient Weight: 118 KG