MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MINI TRAY STD COCR +0 OFFSET; EXTREMITY IMPLANTS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	01/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was revised approximately 3 months post implantation due to an suspected nickel allergy.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).Concomitant medical product(s): catalog #: 405800, comp.Rev shldr 9 in steinmann, lot # 130520; catalog #: 115310, comp rvrs shldr glnsp std 36mm, lot # 886240; catalog #: 180550, comp lk scr 3.5hex 4.75x15 st, lot # 437540; catalog #: 180550, comp lk scr 3.5hex 4.75x15 st, lot # 098780; catalog #: 180551, comp lk scr 3.5hex 4.75x20 st, lot # 918800; catalog #: 180551, comp lk scr 3.5hex 4.75x20 st, lot # 855910; catalog #: 115398, comp rvs cntrl 6.5x40mm st/rst, lot # 655670; catalog #: 010000589, comp rvrs 25mm bsplt ha+adptr, lot # 656600; catalog #: 113611, comp primary stem 11mm micro, lot # 65319533; catalog #: 110031424, cr vivacit-e 36mm brng std, lot # 65434165.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its been requested but not returned by hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-00354, 0001825034-2023-00355, 0001825034-2023-00356, 0001825034-2023-00357, 0001825034-2023-00358, 0001825034-2023-00359, 0001825034-2023-00360, 0001825034-2023-00361, 0001825034-2023-00362, 0001822565-2023-00438.Additional information requested but not returned by hospital.
Additional Manufacturer Narrative
(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined without test results or medical records documenting the patient's allergy to nickel.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: MINI TRAY STD COCR +0 OFFSET
• Common Device Name: EXTREMITY IMPLANTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16410377
• Report Number: 0001822565-2023-00439
• Device Sequence Number: 5378882
• Product Code: KWS
• UDI-Device Identifier: 00887868231315
• UDI-Public: (01)00887868231315(17)320607(10)65398274
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2023

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 Model Number: N/A
• Device Catalogue Number: 110031399
• Device Lot Number: 65398274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Patient Sex: Female