MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN STEMMED TIBIAL COMPONENT PRECOAT SIZE 4; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Malposition of Device (2616); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060)
Date of Event	02/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The customer has indicated that the product will not be returned to zimmer biomet for investigation, as he 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
It was reported that patient underwent right total knee revision approximately 12 years post implantation.Subsequently, patient was revised again approximately 7 months later.The poly and tibia were revised.The tibia was found grossly loose with varus alignment.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Below are the results of the investigation: no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient had first revision for loosening of the tibial plate and a review of the ops note found no complication.The tibial was grossly loose.Scar tissue was noted.No complication was noted during the surgery.The femoral component was well fixed.A definitive root cause cannot be determined.Per package insert: pain, loosening is a known adverse effect of the system.No corrective actions, preventive actions, or field actions resulted after the investigation of this event.The complaint is confirmed.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.
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, g3, g6, h1, h2, h3, h6, and h10.Additional information: d10 - concomitant devices - refobacin bc r 1x40 us catalog #: 110034355 lot # 907cai1801; femoral component option for cemented use only size f right catalog #:00599401692 lot # n/i; stem extension straight15mm dia x 30mmlength (combined length catalog #: 00598801215, lot # 62752765; articular surface usewith lps/lps-flex 51 or 52suffix femorals size ef 12mm height catalog #: 00596203212, lot # 64687730; trabecular metal distal femoral augment block, catalog #: 00549003610, lot # n/i; stem extension straight15mm dia x 30mmlength(combined length75mm) catalog #: 00596203212, lot # 64687730; trabecular metal distal femoral augment block ,catalog #: 00598801215 lot # 62746050; trabecular metal tibial half block augment tapered left lateral/ right medial with screws catalog #: 00544800438.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: NEXGEN STEMMED TIBIAL COMPONENT PRECOAT SIZE 4
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 11753417
• Report Number: 0002648920-2021-00094
• Device Sequence Number: 11644579
• Product Code: JWH
• UDI-Device Identifier: 00889024217584
• UDI-Public: (01)00889024217584(17)300228(10)64690802
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/07/2021

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: 00598003702
• Device Lot Number: 64690802
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 05/03/2021; 06/09/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 05/10/2021; 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 109