MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON #4 PS INSERT 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Model Number	5532-P-409
Medical Device Problem Codes	Degraded (1153); Fracture (1260); Unstable (1667)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	06/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: ps insert removal and replacement of new insert.Original tka occurred approx.12 years ago.Pt presented with "my knee feels less stable".Ps insert post has snapped and insert upon removal presented yellow and brittle.
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture, wear, and instability involving a triathlon insert was reported.The crack/fracture and wear events were confirmed via evaluation of the returned device.Instability was not confirmed.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device was performed as part of the material analysis: material analysis: a material analysis was performed and concluded the following: "review of triathlon #4 ps insert 9mm, catalogue # 5532-p-409, lot code lbh473 confirmed discolouration and material loss on the component.Characterisation using stereo microscopy confirmed discolouration consistent with absorption of synovial fluid and delamination of the component consistent with articulation against the femoral component.Due to extensive material loss, no manufacturing or material related defects could be observed on the component surfaces examined." clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to instability.Visual inspection of the returned device was performed as part of the material analysis: the material analysis concluded the following: "review of triathlon #4 ps insert 9mm, catalogue # 5532-p-409, lot code lbh473 confirmed discolouration and material loss on the component.Characterisation using stereo microscopy confirmed discolouration consistent with absorption of synovial fluid and delamination of the component consistent with articulation against the femoral component.Due to extensive material loss, no manufacturing or material related defects could be observed on the component surfaces examined." no further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The following was reported: ps insert removal and replacement of new insert.Original tka occurred approx.12 years ago.Pt presented with "my knee feels less stable".Ps insert post has snapped and insert upon removal presented yellow and brittle.

• Brand Name: TRIATHLON #4 PS INSERT 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; UK WD6 3SJ
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 15089538
• Report Number: 0002249697-2022-01069
• Device Sequence Number: 5101720
• Product Code: MBH
• UDI-Device Identifier: 07613327042764
• UDI-Public: 07613327042764
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2013
• Device Model Number: 5532-P-409
• Device Catalogue Number: 5532P409
• Device Lot Number: LBH473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2008
• 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; Hospitalization
• Patient Sex: Male