MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. STEMMED NONAUGMENTABLE TIBIAL COMPONENT OPTION CR/PS/LPS SIZE 8; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	12/18/2019
Type of Reportable Event	Serious Injury
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.Concomitant medical products: 00596001851, femoral component, lot # 63880029, 00596205010, articular surface, lot # 63809998.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 00066.0001822565 - 2020 - 00067.
Event or Problem Description
It was reported that approximately 19 months post implantation, the patient was revised due to pain and stiffness.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Udi # (b)(4).Visual evaluation of the returned implants shows signs of being implanted.Bone cement still adhered to the inferior side of the femoral implant, but not on the tibial plate.Dimensions were conforming to the prints.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: mild radiolucency along the bone cement interface of the medial and posterior tibia which could indicate early loosening.A definitive root cause cannot be determined.Per package insert fixed bearing knee: pain is a known adverse effect of this procedure.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: STEMMED NONAUGMENTABLE TIBIAL COMPONENT OPTION CR/PS/LPS SIZE 8
• 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: 9557230
• Report Number: 0002648920-2020-00016
• Device Sequence Number: 2334937
• Product Code: JWH
• UDI-Device Identifier: 00889024218888
• UDI-Public: (01)00889024218888
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00598605702
• Device Lot Number: 63702840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 05/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 116