MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) LEFT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2019-04955.0001822565-2019-04956.Medical products: tibia cemented 5 degree stemmed left, item# 42532006701, lot# 63620694, unknown persona femoral.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it has been discarded.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 one year, eleven months and three weeks post implantation due to pain, tibial and femoral loosening, and a fractured tibial component.At the diagnosis, the tibia base was subsided and the component was loosening.Loosening of the femur component was also confirmed.At the revision procedure, wear was seen on the explanted articular surface and the plastic cap for the explanted tibia component was fractured.There is no additional information at this time.
Additional Manufacturer Narrative
This report is being submitted to update the complaint description and correct the implant date.
Event or Problem Description
It was reported that a patient was revised approximately one year and eleven and a half months post implantation due to pain, tibial and femoral loosening, and a fractured tibial component.At the diagnosis, the tibia base was subsided and the component was loosening.Loosening of the femur component was also confirmed.At the revision procedure, wear was seen on the explanted articular surface and the plastic cap for the explanted tibia component was fractured.There is no additional information at this time.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.D11-medical product femur cemented posterior stabilized (ps) standard left size 6.Item# 42500606001; lot# 63330442.Updated: b4, b5, d11, g4, g7, h1, h2, h3, h6, and h10.Visual examination of the provided pictures confirms pitting/ wear seen on the articular surface and fracture of the tibial stem taper plug.Medical records were not provided.Articular surface wear and tibial fracture was confirmed.Tibial and femoral loosening was not confirmed.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.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: ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) LEFT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9350042
• Report Number: 0001822565-2019-04954
• Device Sequence Number: 14133695
• Product Code: MBH
• UDI-Device Identifier: 00889024237087
• UDI-Public: (01)00889024237087
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121771
• 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,Followup
• Report Date (Section B): 03/25/2020

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: 06/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 42512400510
• Device Lot Number: 63694428
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 11/18/2019; 03/18/2020
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 12/02/2019; 03/25/2020
• 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