MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS TIBIAL POLY BEARING 14MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	10/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent a revision procedure seven days¿ post implantation due to a tendon tear.The poly, bushings, axle, yoke, and locking pin were exchanged.There is no additional information available.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2021-03153, 0001825034-2021-03154, 0001825034-2021-03155, 0001825034-2021-03156, 0001825034-2021-03157.Medical product: oss axle, item# 150480, lot# 138830.Oss poly tibial bushing, item# 150476, lot# 106160.Oss poly femoral bushings, item# 150477, lot# 480940.Oss reinforced yoke, item# 150493, lot# 594180.Oss poly bumper lock pin, item# 150510, lot# 154170.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
It was reported the patient had a tendon repair for a ruptured tendon.A tendon rupture is common in adults.As tendons age, they tolerate less stress, are less elastic and easier to tear.It can be caused by a direct trauma to the knee.The treatment depends on individual pain thresholds, tissue repair rates, and extent of the damage.Tendon ruptures can be treated conservatively or surgically.A rupture can lead to a decrease in knee flexion and aids in walking, running and jumping.It was noted that there were no problems with any of the implants at the time of surgical repair of the tendon rupture and instead components easily exchanged were replaced proactively.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: OSS TIBIAL POLY BEARING 14MM
• Common Device Name: PROSTHESIS, HIP
• 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: 12837106
• Report Number: 0001825034-2021-03158
• Device Sequence Number: 4780379
• Product Code: JDI
• UDI-Device Identifier: 00880304010888
• UDI-Public: (01)00880304010888(17)241210(10)815020
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K002757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2022

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: 12/10/2024
• Device Model Number: N/A
• Device Catalogue Number: 150411
• Device Lot Number: 815020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2021
• Supplement Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 11/18/2021
• Supplement Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male