MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TIB LM/RL TIB AUG SZ3 10MM; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number	5546-A-301
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	12/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding tibial loosening involving a triathlon augment was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as no product was returned for evaluation.Clinician review: not performed as medical records were not provided.Product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Not returned to the manufacturer.
Event or Problem Description
As reported: "patient's left tibial component was revised due to loosening¿all tibial components (12x50 stem, size 3 universal baseplate, two augments, 3x16 ts insert)¿were explanted and revised to triathlon ts.Tibial side as a whole was loosened, no specific implant(s) cited.".

• Brand Name: TIB LM/RL TIB AUG SZ3 10MM
• Common Device Name: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8265295
• Report Number: 0002249697-2019-00238
• Device Sequence Number: 1578198
• Product Code: MBH
• UDI-Device Identifier: 07613327026436
• UDI-Public: 07613327026436
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/21/2019

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: 08/30/2014
• Device Catalogue Number: 5546-A-301
• Device Lot Number: N4E32D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 01/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 56 YR