MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PROVISIONAL STEMMED TIBIAL COMPONENT SIZE 8; TEMPLATE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2020-00191, 0001822565-2020-00192, 0001822565-2020-00193, 0001822565-2020-00194, 0001822565-2020-00195.Concomitant medical products: provisional stemmed tibial component size 3, item# 00598103701, lot# 62165654.Provisional stemmed tibial component size 4, item# 00598103702, lot# 62141742.Provisional stemmed tibial component size 5, item# 00598104701, lot# 61924919.Provisional stemmed tibial component size 6, item# 00598104702, lot# 62129531.Provisional stemmed tibial component size 7, item# 00598105701, lot# 63631854.Foreign report source: (b)(6).Customer has indicated that the product will 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 it was reported that the trials had cracks in the plastic.This was discovered prior to surgery.There is no additional information at this time.
Additional Manufacturer Narrative
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: PROVISIONAL STEMMED TIBIAL COMPONENT SIZE 8
• Common Device Name: TEMPLATE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9592449
• Report Number: 0001822565-2020-00196
• Device Sequence Number: 667349
• Product Code: HWT
• UDI-Device Identifier: 00889024217775
• UDI-Public: (01)00889024217775
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00598105702
• Device Lot Number: 63660426
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 03/19/2020
• 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