MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SERIES A PAT STD 28 3 PEG; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10-medical product vngd ssk psc tib brg 16x71/75 item# 183886 lot# 66280240 vngd ssk psc tib brg 18x71/75 item# 183888 lot# 66703287 biomet tibial locking bar item# 141205 lot# 66177055 biomet tibial locking bar item# 141205 lot# 65766382 vngd ssk 360 l fem 70mm item# 185286 lot# 7269588 bmt splined knee stm v2 13x160 item# 148327 lot# 600100 vg 360 dst fm ag 70x10 rl/lm item# 185386 lot# 66059614 vg 360 dst fm ag 70x10 ll/rm item# 185406 lot# 66044535 vg 360 univ pst fm aug 70x5 item# 185346 lot# 66303815 biomet cc cruciate tray 75mm item# 141234 lot# j6180136 vngd ssk 360 l fem 70mm item# 185286 lot# 7269588 h3- 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
It was reported that a patient was revised approximately seven months post implantation due to instability and patellar loosening.There is no additional information available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, d2, g1, g3, g6, h1, h2, h3, h6, and h11.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: no implant loosening is identified.There are two suspected avulsion fragments from the inferior pole of the patella.Although not seen radiographically, this may be associated with patellar implant loosening.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot be determined.This complaint is not confirmed.If any further information is received which would change or alter any conclusions or information, a supplemental medwatch will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: SERIES A PAT STD 28 3 PEG
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20415827
• Report Number: 0001825034-2024-02392
• Device Sequence Number: 12817485
• Product Code: JWH
• UDI-Device Identifier: 00880304431638
• UDI-Public: (01)00880304431638(17)230209(10)065860
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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 Expiration Date: 02/09/2023
• Device Model Number: N/A
• Device Catalogue Number: 184762
• Device Lot Number: 065860
• 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: 09/18/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2018
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female