MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MOD ARTHRO NL 1CM ELIP CNCTR; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent a revision procedure one year post implantation due to implant fracture.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.D10 - medical product: mod arthro nl 1cm elip cnctr catalog # cp260606 lot # 075550; oss cemented im stem 14x150 catalog # 150368 lot # 549900; mod arthro xl hd sm thd lk scr catalog # cp260610 lot # 410170; mod arthro xl hd sm thd lk scr catalog # cp260610 lot # 082520; oss cmntd prox tib stem 13x150 catalog # 150446 lot # 092830; d arthro nl lock collar scr catalog # cp260604 lot # 051420; mod arthro 5 deg lck collar catalog # cp260601 lot # 803080.H3: customer has indicated that the product will not be returned because product location is unknown.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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.No medical records were provided.X-ray review by mmi confirm fracture of the tibial connector of the right knee oss system arthroplasty with resulting varus alignment.Bone quality is osteopenic.A definitive root cause cannot be determined.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: MOD ARTHRO NL 1CM ELIP CNCTR
• 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: 15186680
• Report Number: 0001825034-2022-01801
• Device Sequence Number: 17618751
• Product Code: HSB
• UDI-Device Identifier: 00880304083035
• UDI-Public: (01)00880304083035(17)291113(10)119450
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K042409
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CP260606
• Device Lot Number: 119450
• 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: 07/19/2022
• Supplement Date Received by Manufacturer: 11/08/2022; 12/05/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 12/01/2022; 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2019
• 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 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 162 KG