MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON MB PATELLA PA A32; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5554-L-320
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348); No Code Available (3191)
Date of Event	05/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Primary surgery with triathlon patella pa was performed on (b)(6) 2017.After that fracture of the patella was found, the revision surgery is planned on (b)(6) 2017.
Additional Manufacturer Narrative
An event regarding periprosthetic fracture involving a titanium patella was reported.The event was confirmed through x-ray.Device evaluation and results: visual inspection of the returned patellar component indicates that the device is unremarkable other than expected evidence of in-vivo use on the beaded in-growth surface.Medical records received and evaluation: a review of the provided x-rays by a clinical consultant indicated an adverse mix of patient-related (osteoporosis) and procedure-related factors (surgical preparation in osteoporotic bone) have caused a peri-prosthetic fracture of the patella early post arthroplasty requiring revision surgery.Device history review: the 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 medical review indicated that an adverse mix of patient-related (osteoporosis) and procedure-related factors (surgical preparation in osteoporotic bone) have caused a peri-prosthetic fracture of the patella early post arthroplasty requiring revision surgery.No further investigation for this event is possible at this time, should additional information become available, this investigation will be reopened.
Event or Problem Description
Primary surgery with triathlon patella pa was performed on (b)(6) 2017.After that fracture of the patella was found, the revision surgery is planned on (b)(6) 2017.

• Brand Name: TRIATHLON MB PATELLA PA A32
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6633178
• Report Number: 0002249697-2017-01834
• Device Sequence Number: 231508
• Product Code: MBH
• UDI-Device Identifier: 07613327049893
• UDI-Public: (01)07613327049893(11)161219(17)211219(10)AS83H
• Combination Product (Y/N): N
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2017

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: 12/19/2021
• Device Model Number: 5554-L-320
• Device Catalogue Number: 5554L320
• Device Lot Number: AS83H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2017
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: 09/28/2017
• Initial Report FDA Received Date: 06/12/2017
• Supplement Report FDA Received Date: 10/25/2017
• 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: 87 YR
• Patient Weight: 47