MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR INSERT X3 #5 LM/RL -8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	5630-G-508
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthritis (1723); Pain (1994)
Date of Event	09/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.The following devices were also listed in this report: triathlon pkr femur #5 lm/rl; cat#5610-f-501 ; lot#fytk triathlon pkr baseplate #5 lm/rl; cat#5620-b-501 ; lot#jrela it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.H3 other text : device not returned to the manufacturer.
Event or Problem Description
This is a study subject in the triathlon pkr outcomes study.The site attributed this to a sports injury.The subject had his original pkr surgery on (b)(6) 2016 for the medial compartment.On (b)(6), 2017, an adverse event was reported noting progression of osteoarthritis on the lateral compartment and patella-femoral area treated with several injections of supartz and steroids.The event was considered resolved as of (b)(6) 2017.On (b)(6) 2018, it was reported that the subject sustained a trauma and experienced a lateral meniscus tear.A plm and chondroplasty was performed via arthroscopy on (b)(6) 2018 and the event was considered resolved.At this time, it was observed that there were grade 2-3 changes in patella-femoral and grade 3-4 changes in lateral compartment.On (b)(6) 2018, it was noted that there was progression of the arthritic degeneration in the lateral compartment and the subject started complaining about more pain.It was decided to convert the medial triathlon pkr to a total knee.
Additional Manufacturer Narrative
Corrected data - explant date reported event an event regarding patient factors involving a triathlon insert was reported.The event was confirmed through clinician review of the provided medical records.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: confirmation: a revision surgery (conversion from a medial unicompartmental knee to a total knee) can be confirmed.A reported arthroscopy with partial lateral meniscectomy was reported but not confirmed.A chondroplasty was not confirmed.Progression of lateral compartment arthritis and injection therapy was confirmed.Root cause: the root cause of the revision surgery was progression/development of lateral compartment arthritis and failure of conservative measures/injection therapy.The root cause of the lateral compartmental arthritis cannot be confirmed but may in part to a related to a reported trauma and lateral meniscectomy/chondroplasty and/or slight over correction.Device history review: all 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 reported lot.Conclusion: a review of the provided medical records by a clinical consultant stated the following comment: confirmation: a revision surgery (conversion from a medial unicompartmental knee to a total knee) can be confirmed.A reported arthroscopy with partial lateral meniscectomy was reported but not confirmed.A chondroplasty was not confirmed.Progression of lateral compartment arthritis and injection therapy was confirmed.Root cause: the root cause of the revision surgery was progression/development of lateral compartment arthritis and failure of conservative measures/injection therapy.The root cause of the lateral compartmental arthritis cannot be confirmed but may in part to a related to a reported trauma and lateral meniscectomy/chondroplasty and/or slight over correction.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
This is a study subject in the triathlon pkr outcomes study.The site attributed this to a sports injury.The subject had his original pkr surgery on (b)(6) 2016 for the medial compartment.On 4/18/2017, an adverse event was reported noting progression of osteoarthritis on the lateral compartment and patella-femoral area treated with several injections of supartz and steroids.The event was considered resolved as of 8/25/2017.On 2/16/2018, it was reported that the subject sustained a trauma and experienced a lateral meniscus tear.A plm and chondroplasty was performed via arthroscopy on (b)(6)2018 and the event was considered resolved.At this time, it was observed that there were grade 2-3 changes in patella-femoral and grade 3-4 changes in lateral compartment.On (b)(6) 2018, it was noted that there was progression of the arthritic degeneration in the lateral compartment and the subject started complaining about more pain.It was decided to convert the medial triathlon pkr to a total knee.

• Brand Name: TRIATHLON PKR INSERT X3 #5 LM/RL -8MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 13017972
• Report Number: 0002249697-2021-02050
• Device Sequence Number: 20130735
• Product Code: HRY
• UDI-Device Identifier: 07613327016062
• UDI-Public: 07613327016062
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K071881
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2022

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: 10/30/2020
• Device Model Number: 5630-G-508
• Device Catalogue Number: 5630-G-508
• Device Lot Number: NN18VW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 03/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2015
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White