MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2020-03-24 for TRIATHLON PRIM TIB BASEPLATE - CEMENTED 5520-B-600 manufactured by Stryker Orthopaedics-mahwah.
[185045450]
An event regarding subsidence and instability involving a triathlon baseplate was reported. The event was confirmed based on the clinician review. Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted. Clinician review: a review of the provided medical records and x-rays by a clinical consultant revealed: persistent relative varus deformity across the knee with a tibio-femoral angle of only 1? Valgus post primary arthroplasty in combination with baseplate only cementation and non-anatomic reconstruction of posterior tibial slope have in concert contributed to an overload condition in the left knee with global instability as adverse outcome quite likely with also fixation failure of the baseplate playing a relevant role to require revision surgery within 6-years in jan 2015. Morbid obesity of the patient (bmi=35) represents a relevant secondary factor to aggravate the overload condition. The fixation problems of left knee baseplate were not recognised during the first revision and due to persistent complaints required a second revision only 1? -year later in (b)(6) 2016 for gross tibial cixation failure proven during this second revision surgery. After this, good clinical results were achieved as far as clinical records allow to conclude until (b)(6) 2018. No device-related factors are associated with any of the implanted devices at any time. Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies. Complaint history review: there have been no other similar events for the lot referenced. Conclusions: the medical review indicated that procedure factors including persistent relative varus deformity deformity across the knee with a tibio-femoral angle of only 1? Valgus post primary arthroplasty, baseplate only cementation leaving the keel of the baseplate without cement support in compromised bone and non-anatomic reconstruction of posterior tibial baseplate slope and patient factors morbid obesity of the patient (bmi=35) as relevant secondary factor contributes to the reported event. No device-related factors are associated with any of the implanted devices at any time. No further investigation for this event is required at this time. If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Patient Sequence No: 1, Text Type: N, H10
[185045451]
Patient had joint laxity so took out original ps poly and replaced with a thicker poly. Update 24-may-2019: it was reported through the communication of an attorney that allegedly the patient was revised due to "global instability of the left knee following left total knee arthroplasty, with thin polyethylene". Update 26-feb-2020: based on medical review: x-rays of the left knee around 6-months follow-up on (b)(6) 2010, show demarcation between the baseplate and the bone cement. There is a suggestion of subsidence on the medial side of the baseplate x-rays post first left knee revision on (b)(6) 2015, confirm a thicker bearing in place with otherwise retained femoral component, tibial baseplate and patellar device. Some radiolucent line formation is still evident below the medial baseplate section with questionable overall stability.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2020-00590 |
| MDR Report Key | 9873501 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-27 |
| Date of Event | 2015-01-27 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2009-11-14 |
| Date Added to Maude | 2020-03-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. COLLIN NEITZEL |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS-MAHWAH |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIATHLON PRIM TIB BASEPLATE - CEMENTED |
| Generic Name | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO |
| Product Code | MBH |
| Date Received | 2020-03-24 |
| Returned To Mfg | 2019-07-09 |
| Model Number | 5520-B-600 |
| Catalog Number | 5520-B-600 |
| Lot Number | ZWEX |
| Device Expiration Date | 2014-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOPAEDICS-MAHWAH |
| Manufacturer Address | 325 CORPORATE DRIVE MAHWAH NJ 07430 US 07430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-24 |