MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN STEMMED TIBIAL COMPONENT PRECOAT SIZE 5; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Osteopenia/ Osteoporosis (2651)
Date of Event	05/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical product(s): 00-5964-017-52 63439144 nexgen, femoral component; 00-5964-42-12 63313487 nexgen, articular surface; 00-5988-012-15 63240780 nexgen straight stem extension 15 x 75 mm; 00112114001 16ga18720 hi-fatigue bone cement.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the hospital will not allow.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 the patient that the patient was revised due to implant fracture approximately 2 years post implantation.The patient started experiencing severe pain in his knee and was unable to walk.No additional patient consequences were reported.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.D4: udi # (b)(4).This complaint is confirmed.No product was returned; visual and dimensional evaluations could not be performed.Photographs provided confirms that the tibial tray is fractured.The bearing shows damage consistent with contact with the fractured tibial component.Review of the device history record identified no deviations or anomalies during manufacturing.X-ray review by mmi confirms fracture of the tibial implant with subsidence of the fractured medial tray.Bone quality was found to be osteopenic with marked cortical bone thinning.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: NEXGEN STEMMED TIBIAL COMPONENT PRECOAT SIZE 5
• 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: 9142095
• Report Number: 0002648920-2019-00708
• Device Sequence Number: 19585152
• Product Code: JWH
• UDI-Device Identifier: 00889024217607
• UDI-Public: 00889024217607
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2020

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: 08/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 00598004701
• Device Lot Number: 63464847
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/22/2019
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 03/17/2020
• 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 Age: 60 YR
• Patient Weight: 130