MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS SEGMENTAL STACKING ADAPTER; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/30/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2016-03780.0001825034-2019-04426.0001825034-2019-04427.0001825034-2019-04425.0001825034-2019-04428.0001825034-2019-04429.0001825034-2019-04430.0001825034-2019-04431.0001825034-2019-04432.0001825034-2019-04433.Concomitant medical products: 150410, oss tibial poly bearing 12mm, lot # 520820, 150467 oss 9cm diaphyseal segment, lot # 289150, 150476, poly tibial bushing, lot # 143560, 150477, poly femoral bushing, lot # 050320, 150478, oss poly lock pin, lot # 143560, 150465, oss 5 cm diaphyseal segment, lot # 508870, 150479, oss reinforced yoke, lot # 125790, 150367, oss cemented im stem, lot # 240470, 150480, oss axle, lot #178390.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that approximately 7 years post implantation, the patient was revised due to unknown reasons.Attempts have been made and no further information has been provided.

• Brand Name: OSS SEGMENTAL STACKING ADAPTER
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9739742
• Report Number: 0001825034-2020-00836
• Device Sequence Number: 16689238
• Product Code: JDI
• UDI-Device Identifier: 00880304239999
• UDI-Public: (01)00880304239999
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K011455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/21/2020

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 Expiration Date: 03/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 150483
• Device Lot Number: 005490
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 02/21/2020
• 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