MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN INSTRUMENT; INSTRUMENT- KNEE

Model Number N/A

Device Problem Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant devices -tibia cemented 5 degree stemmed right size g catalog # 42532007902 lot #: 64831313, articular surface fixed bearing ultracongruent (uc) right 14 mm height catalog # 42522200614 lot #: 63722485; unknown instrument catalog # n/i lot #: n/i.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 3007963827 - 2021 - 00244, 3007963827 - 2021 - 00245, 0001822565 - 2021 - 03056.

Event Description

It was reported that after the tibia and femur were cemented, the surgeon felt that there was an issue with the anterior portion of the tibia where the poly insertion instrument engages for final poly insertion.The instrument would not engage correctly and the poly wouldn't seat.Attempts have been made and no further information has been provided.

Event Description

Upon further evaluation of the event, it was determined that this event is nonreportable and the first report was submitted erroneously.There was no serious injury nor has one occurred in the past.Please void the first report.

Manufacturer Narrative

Upon further evaluation of the event, it was determined that this event is nonreportable and the first report was submitted erroneously.There was no serious injury nor has one occurred in the past.Please void the first report.

• Brand Name: UNKNOWN INSTRUMENT
• Type of Device: INSTRUMENT- 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: 12669561
• MDR Text Key: 280008390
• Report Number: 0001822565-2021-03056
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN INSTRUMENT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 78 KG