MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. STEM EXTENSION STRAIGHT 11MM DIA X 100MM LENGTH; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2021-02301, 0001822565-2021-02302, 0001822565-2021-02303, 0002648920-2021-00223, and 0002648920-2021-00225.Medical product: femoral component size e left , item# 00588001501, lot# 62958321.Tibial component precoat size 4, item# 00588000400, lot# 63185060.Articular surface with hinge post, item# 00588005012, lot# 63256586.All poly patella standard size 32 mm diameter 8.5 mm thickness, item# 00597206532, lot# 63382530.Stem extension straight long 14mm dia x 155mm length, item# 00598801114, lot# 37214059.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 a patient was revised approximately four years and ten months¿ post implantation due to unknown reasons.Attempts to obtain additional information have been made; however, no more information is available at this time.
Additional Manufacturer Narrative
Upon reassessment of the reported event, this device was determined to not be reportable as it was not involved in the event.The initial report was submitted in error and should be voided.
Event or Problem Description
Upon reassessment of the reported event, this device was determined to not be reportable as it was not involved in the event.The initial report was submitted in error and should be voided.

• Brand Name: STEM EXTENSION STRAIGHT 11MM DIA X 100MM LENGTH
• 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: 12348835
• Report Number: 0002648920-2021-00224
• Device Sequence Number: 4191481
• Product Code: JWH
• UDI-Device Identifier: 00889024220959
• UDI-Public: (01)00889024220959(17)250531(10)62893869
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K933785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2021

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 Expiration Date: 05/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 00598801011
• Device Lot Number: 62893869
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 09/28/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention