MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ORTHOPEDIC SALVAGE SYSTEM FEMORAL BUSHING; PROSTHESIS, KNEE

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Date 04/21/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Ogura, k., yakoub, m.A., boland, p.J., healey, j.H.(21 apr 2021).Finn/orthopaedic salvage system distal femoral rotating-hinge megaprostheses in oncologic patients.The journal of bone and joint surgery, inc.103 (8), 705-714.Http://doi.Org/10.2106/jbjs.20.00696.Concomitant devices - unknown orthopedic salvage system tibial stem catalog #: ni lot #: ni, 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 locking pin catalog #: ni lot #: ni.Occupation- correspondence author.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: 0001825034-2022-01044, 0001825034-2022-01045.

Event Description

It was reported that nineteen (19) patients underwent an additional knee operation to address unspecified polyethylene complications post-operatively.Attempts have been made, however, no additional information is available.

Event Description

No further event information at time of this report.

Manufacturer Narrative

Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: UNKNOWN ORTHOPEDIC SALVAGE SYSTEM FEMORAL BUSHING
• 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: 14316116
• MDR Text Key: 291207980
• Report Number: 0001825034-2022-01046
• 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: 05/12/2022

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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose