MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. STEM EXTENSION STRAIGHT LONG 12MM DIA X 155MM LENGTH(COMBINED LENGTH 200MM); PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Fall (1848)
Date of Event	10/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Year of birth: (b)(6).Concomitant medical devices: 00588001602 64652974 femoral component option for cemented use only size f right; 00599003610 64087753 distal femoral augment block.Foreign country: (b)(6).Complaint sample was evaluated and the reported event was not confirmed.Visual evaluation of returned implants shows signs of being in vivo.Some surface scratches were seen in the femoral component.The cement adhered to the back of the implant.Taper junction of the stem extension shows some damages which can be related to explanation damages.Augments and hinge system was still attached to the femoral implant.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-03562, 0001822565 - 2021 - 00493.
Event or Problem Description
It was reported that a left leg amputee stood up from his wheel chair on his right leg, twisted and fell.Subsequently, the patient was revised approximately one month post implantation due to unknown reason.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: STEM EXTENSION STRAIGHT LONG 12MM DIA X 155MM LENGTH(COMBINED LENGTH 200MM)
• 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: 11373297
• Report Number: 0002648920-2021-00032
• Device Sequence Number: 11707707
• Product Code: JWH
• UDI-Device Identifier: 00889024221062
• UDI-Public: (01)00889024221062(17)290531(10)64400895
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/23/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00598801112
• Device Lot Number: 64400895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 02/24/2021
• 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 Age: 74 YR
• Patient Weight: 120