MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE WITH LOCKING SCREW; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent a revision procedure eight years post implantation due to aseptic loosening and oxidation.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
(b)(4).Implant date: (b)(6) 2013.Conocmitant medical products: tibial block and screws precoat size 4 5 mm thickness, catalog #: 00598800426 x2, lot #: unk.Stemmed tibial component precoat size 4 for cemented use only use of this tibial component with lcck articulating surfaces requires using a stem exten, catalog #: 00598003702, lot #: unk.Prc agmt block dist sz e 5mm, catalog #: 00599003510 x2, lot #: unk.Femoral component option for cemented use only size e left, catalog #: 00599401591, lot #: unk.Prc agmt block post sz e 10mm catalog # 00599003502 lot # unk stem extension straight 13mm dia x 100mm length(combined length 145mm) catalog # 00598801013 lot # unk stem extension offset 12mm dia x 100mm length(combined length 145mm) catalog # 00598802012 lot # unk g2: france h3: customer has indicated that the product will not be 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.Updated: b4, b5, d4, d6a, e1, g3, g6, h1, h2, h4, h10.D11: tibial block and screws precoat size 4 5 mm thickness catalog # 00598800426 x2 lot # 63548548.Stemmed tibial component precoat size 4 for cemented use only use of this tibial component with lcck articulating surfaces requires using a stem exten catalog # 00598003702 lot #64131315.Prc agmt block dist sz e 5mm catalog # 00599003510 x2 lot # 62830060.Femoral component option for cemented use only size e left catalog # 00599401591 lot # 64096819.Prc agmt block post sz e 10mm catalog # 00599003502 lot # 63203931.Stem extension straight 13mm dia x 100mm length(combined length 145mm) catalog # 00598801013 lot # 64063585.Stem extension offset 12mm dia x 100mm length(combined length 145mm) catalog # 00598802012 lot # 63960517.Tibial block and screws precoat size 4 5 mm thickness catalog # 00598800426 lot # 63795136.Prc agmt block dist sz e 5mm catalog # 00599003510 lot # 63166387.
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.Reported event was unable to be confirmed due to limited information received from the customer.Visual evaluation of the returned device shows signs of repeated use with wear.All implants were disassembled.Locking screw was not returned for evaluation.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.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: ARTICULAR SURFACE WITH LOCKING SCREW
• Common Device Name: 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: 14347181
• Report Number: 0001822565-2022-01362
• Device Sequence Number: 4698135
• Product Code: JWH
• UDI-Device Identifier: 00889024635760
• UDI-Public: (01)00889024635760(17)260430(10)64015782
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2022

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 Expiration Date: 04/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 00599403214
• Device Lot Number: 64015782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/29/2022
• Supplement Date Received by Manufacturer: 05/23/2022; 08/10/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 06/07/2022; 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2018
• 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
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown