MAUDE Adverse Event Report: STRYKER GMBH SLIDING CORE UHMPWE, 7MM; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME

Catalog Number 400141

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 09/27/2018

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.

Event Description

It was reported that patient's ankle was revised.Patient complaints, pre-operative diagnoses, intra-operative findings were not reported to the rep.Talar component and poly were explanted and a cement spacer placed.Tibial component was well-fixed and well-positioned and not revised.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.

Manufacturer Narrative

The reported event that sliding core uhmpwe, 7mm was alleged of 'revision' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.In the case presented a patient had been treated with star in 2011.On september, 2018 the patient had to be revised in the ankle.The talar and sliding core of the total ankle replacement were removed and replaced by a cement spacer.The product was not returned for analysis and no x-rays or the outstanding patient data (e.G weight, height, pre-existing illnesses, unreasonable stresses) were provided for clinical assessment.Overall the results of the stage 1 analysis are consistent with well-positioned and well-functioning devices implanted for approximately 7 years.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that patient's ankle was revised.Patient complaints, pre-operative diagnoses, intra-operative findings were not reported to the rep.Talar component and poly were explanted and a cement spacer placed.Tibial component was well-fixed and well-positioned and not revised.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.

Manufacturer Narrative

The reported event that sliding core uhmpwe, 7mm was alleged of 'revision' 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 such as x-rays as well as the affected device must be available in order to determine the root cause of the complaint event.The operative reports provided were sent to stryker's medical expert for analysis in order to find a root cause to the reported event, and their statement following the study states, the first procedure seems to have gone without any problems.The major revision in 2018 (pi 1915653) resulted in a girdle stone procedure removing the talar aspect of the prosthesis, probably this was done because of suspected loosening.Besides the existence of bony overgrowth, which is not desirable, the report shows no specific pathological reason for this loosening.Biopsies were taken though.Six months after this girdle stone procedure an entire new prosthesis was placed, while extra precautions were taken to treat infection while placing this new implant.The reason for the first one to fail might be aseptic infection, that is what me and my colleague conclude from the reports.In conclusion, the most probable root cause for the reported event is aseptic infection, even though nothing can be confirmed without the presence of the different x-rays of this patient.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 did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that patient's ankle was revised.Patient complaints, pre-operative diagnoses, intra-operative findings were not reported to the rep.Talar component and poly were explanted and a cement spacer placed.Tibial component was well-fixed and well-positioned and not revised.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.

• Brand Name: SLIDING CORE UHMPWE, 7MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8006621
• MDR Text Key: 125099009
• Report Number: 0008031020-2018-00904
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 400141
• Device Lot Number: 1311202
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention