MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ORTHOPEDIC SALAVAGE SYSTEM TIBIAL STEM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Date 08/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Ogura, k., fujiwara, t., morris, c.D., boland, p.J., healey, j.H.(1 aug 2021).Long-term competing risks for overall and cause-specific failure of rotating-hinge distal femoral arthroplasty for tumour reconstruction.The bone & joint journal.103-b (8), 1405-1413 https://doi.Org/10.1302/0301-620x.103b8.Bjj-2020-2323.R1 concomitant devices - unknown orthopedic salvage system femoral stem catalog #: ni lot #: ni, unknown orthopedic salvage system femoral component catalog #: ni lot #: ni, unknown orthopedic salvage system tibial tray catalog #: ni lot #: ni, unknown orthopedic salvage system tibial bearing catalog #: ni lot #: ni, unknown orthopedic salvage system yoke catalog #: ni lot #: ni, unknown orthopedic salvage system axel catalog #: ni lot #: ni, unknown orthopedic salvage system tibial bushing catalog #: ni lot #: ni, unknown orthopedic salvage system femoral bushings catalog #: ni lot #: ni, unknown orthopedic salvage system locking pin catalog #: ni lot #: ni (b)(6).The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the location of the device is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001825034-2022-01025, 0001825034-2022-01026, 0001825034-2022-01027, 0001825034-2022-01028, 0001825034-2022-01029, 0001825034-2022-01030, 0001825034-2022-01031, 0001825034-2022-01032, 0001825034-2022-01033.

Event Description

It was reported that twenty-seven (27) patients underwent knee arthroplasty revisions to address an unspecified structural failure post-operatively.Attempts have been made, however, no additional information is available.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

H6 - component code - proposed code is mechanical (g04) - stem.The device history records could not be reviewed as the lot number associated with the reported event is unknown.A definitive root cause could not be determined with the information provided.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.

• Brand Name: UNKNOWN ORTHOPEDIC SALAVAGE SYSTEM TIBIAL STEM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14316134
• MDR Text Key: 291213557
• Report Number: 0001825034-2022-01024
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose