MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIAL STEM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number UNK_JR

Device Problem Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 05/05/2021

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Stryker rep reported that during a revision triathlon case where we encountered difficulties removing the trial components from the tibia.Ultimately a triathlon ps femur, a universal triathlon baseplate, 11mm ts insert and 150mm x 10 mm stem were used but due to the difficulties of the case the baseplate was implanted without cement and secured with dall miles, considerable bone graft and dbx putty.(b)(6) 2021 update per sales rep: it was not a revision, it was a complex primary procedure using stryker ts instruments and implants for the tibia., to repeat no stryker products were removed.The trial stem, offset and baseplate were difficult to remove.There was a pre existing tibial fracture and the surgeon was using the ts stem, offset and universal base plate system to by pass the fracture site whilst implanting a primary triathlon ps femoral component.Update (b)(6) 2021 (b)(6): original event reported by sales agent: yesterday i attended a very difficult revision triathlon case where we encountered tremendous difficulties removing the trial components from the tibia.It added over 60 mins to the procedure and the trial stem would not come out without use of various punches, slap hammers and osteotomes.Ultimately a triathlon ps femur, a universal triathlon baseplate, 11mm ts insert and 150mm x 10 mm stem were used but due to the difficulties of the case the baseplate was implanted without cement and secured with dall miles, considerable bone graft and dbx putty.

• Brand Name: UNKNOWN TRIAL STEM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: joann lavatelli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11906907
• MDR Text Key: 256709589
• Report Number: 0002249697-2021-00949
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2021

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 Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 05/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention