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

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); No Information (3190)
Date of Event	01/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 3007963827-2020-00047.Concomitant medical products: tibia cemented 5 degree stemmed left item# 42532007901 lot# 63519234.Repot 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 is being considered for a revision due to unknown reasons.There is no additional information at this time.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated report: 3007963827-2020-00047.0001822565-2020-00711.D11-medical products tibia cemented 5 degree stemmed left item# 42532007901 lot# 63519234.Unknown persona femoral.
Event or Problem Description
It was reported that a patient is being considered for a revision due to tibial pain.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.No product was returned or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related 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 MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 9707615
• Report Number: 0002648920-2020-00083
• Device Sequence Number: 14321413
• Product Code: JWH
• UDI-Device Identifier: 00889024234604
• UDI-Public: (01)00889024234604
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2020

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: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 42511400911
• Device Lot Number: 62989918
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 02/14/2020; 04/29/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 03/03/2020; 05/04/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10; SEE H10
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 100