MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5530-G-609

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 08/23/2016

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Revision right knee replacement done today.Surgeon asked to send away extracted tibial bearing.He has asked if it could be tested to see if anything unusual is discovered.The tibial bearing was replaced and the patella was resurfaced only.Other components from primary knee replacement were left intact.

Manufacturer Narrative

An event regarding a revision involving a triathlon insert was reported.Upon investigation, used error was confirmed.Method & results: device evaluation and results: damage was observed on the anterior and distal surfaces, consistent with the explantation process.Impression markings were also observed on the distal surface of the insert, consistent with contact against the baseplate.Burnishing, scratches and third-body indentations were observed on the articulating surface of the insert.These are common damage modes of uhmwpe (ultra-high molecular weight polyethylene in total joint replacement,).Medical records received and evaluation: revision of triathlon cr tibial bearing 1½-year post arthroplasty as required for removal of a residual piece of plastic drain tube left in the joint after surgery.The cr 9-mm tibial bearing was replaced with an 11-mm cs type while also the patella was resurfaced that had been left unresurfaced initially.The presence of the residual drain piece was confirmed by ct-scan, no other issues were reported during revision.Device history review: indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the reported lot referenced.Conclusion: based on the comments from the clinical consultant, revision of triathlon cr tibial bearing 1½-year post arthroplasty as required for removal of a residual piece of plastic drain tube left in the joint after surgery.The cr 9-mm tibial bearing was replaced with an 11-mm cs type while also the patella was resurfaced that had been left unresurfaced initially.The presence of the residual drain piece was confirmed by ct-scan, no other issues were reported during revision other than some scoring of the femoral component by remnants of the drain tube.The bearing ¿did not look too bad¿ but was replaced.The indication for revision was provided not by any malfunction of one of the implanted devices but for removal of residual plastic pieces of drainage tube left in the joint after he surgery of (b)(6) 2015 as confirmed by ct-scan.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.

Event Description

Revision right knee replacement done today.Surgeon asked to send away extracted tibial bearing.He has asked if it could be tested to see if anything unusual is discovered.The tibial bearing was replaced and the patella was resurfaced only.Other components from primary knee replacement were left intact.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5959113
• MDR Text Key: 54999144
• Report Number: 0002249697-2016-02966
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 5530-G-609
• Device Lot Number: LDQ739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2014
• 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: 64 YR