MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. UNKNOWN SLIDING CORE, UHPWE (STAR); PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Catalog Number UNK_SEL

Device Problems Break (1069); Material Fragmentation (1261); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 05/19/2022

Event Type  Injury  

Event Description

It was reported that a star poly seemed misplaced.Upon removal, the poly had shattered in pieces.The surgical site was cleared in full of any debris and the rest of the construct was removed.The doctor stated that the tar construct have been implanted over 10 years ago.To correct the ankle, a panta nail was inserted.

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It was reported that a star poly seemed misplaced.Upon removal, the poly had shattered in pieces.The surgical site was cleared in full of any debris and the rest of the construct was removed.The doctor stated that the tar construct have been implanted over 10 years ago.To correct the ankle, a panta nail was inserted.

Manufacturer Narrative

Please note correction to d9/h3 as the device was not returned for evaluation.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event, the patient information as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling was not possible because the catalog number and lot number were not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition unknown.

Manufacturer Narrative

Please note correction to d9/h3 as the device was not returned for evaluation.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event, the patient information as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling was not possible because the catalog number and lot number were not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text: device disposition unknown.

Event Description

It was reported that a star poly seemed misplaced.Upon removal, the poly had shattered in pieces.The surgical site was cleared in full of any debris and the rest of the construct was removed.The doctor stated that the tar construct have been implanted over 10 years ago.To correct the ankle, a panta nail was inserted.

• Brand Name: UNKNOWN SLIDING CORE, UHPWE (STAR)
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758 6313
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14787239
• MDR Text Key: 294580741
• Report Number: 0001644408-2022-03005
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male