MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS TRANSVERSE PIN 6PK 36MM; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: cps short anchor plug catalog # 178558 lot # 608690.Cps nut co-cr-mo alloy catalog # 178512 lot # 987740.Cps/oss 5cm tpr adapt w/oss sc catalog # 178711 lot # 779090.Cps sm sht spdl w pins 800lbf catalog # 178367 lot # 625750.Cps centering sleeve 19mm catalog # 178541 lot # 743560.Oss 3cm diaphysel segment catalog # 150464 lot # 854640.Customer has indicated that the product will not be returned because product location is unknown.Complaint sample was evaluated and the reported event was confirmed.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.X-ray review indicates there is a clearly visible fracture in the implant at the interface between the interosseous component and the diaphysis component without surrounding bone.The fracture results in mild displacement laterally of the distal component.Also noted as a linear hardware component which is displaced medial to the cortex at the site of the hardware fracture.The bone quality appears overall normal, although there has been no integration of the bone to the hardware with wide gaps between the hardware and adjacent bone.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the patient underwent an orthopedic salvage procedure.Subsequently, the patient was revised due to fractured traction bar.Attempts for further information has been made, but no further information has been provided.

• Brand Name: CPS TRANSVERSE PIN 6PK 36MM
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10147985
• Report Number: 0001825034-2020-02313
• Device Sequence Number: 2101595
• Product Code: LPH
• UDI-Device Identifier: 00880304260535
• UDI-Public: (01)00880304260535
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K043547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/10/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 178528
• Device Lot Number: 942320
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 06/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 118