MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MINI TRAY STD TI +6 OFFSET; PROSTHESIS, EXTREMITY

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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Product code: phx.Concomitant medical products: catalog#: 113629 comp primary stem 9mm mini lot#: 190250.Catalog#: 010000589 comp rvrs 25mm bsplt ha+adptr lot#: 049210.Catalog#: ti-115310 comp vrsdl glnspr 36mm ti lot#: 211620.Catalog#: 115395 comp rvs cntrl 6.5x25mm st/rst lot#: 526270.Catalog#: 180551 comp lk scr 3.5hex 4.75x20 st lot#: 805130.Catalog#: 180552 comp lk scr 3.5hex 4.75x25 st lot#: 461970.Catalog#: 180553 comp lk scr 3.5hex 4.75x30 st lot#: 980730.Catalog#: 180554 comp lk scr 3.5hex 4.75x35 st lot#: 997650.Catalog#: 110031418 cr prolong 36mm brng std lot#: 64578844.Catalog#:118000 25mm versa-dial taper adaptor lot#: 399130.The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.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: 0001825034-2021-00692, 0001825034-2021-00693, 0001825034-2021-00694.
Event or Problem Description
It was reported that approximately 8 months post implantation the patient is experiencing itching in and around the shoulder and all over his body.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported issue is attributed to the patient's condition - allergy to cobalt.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 is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.A definitive root cause cannot be determined.Patient noted allergy to cobalt, however, all implanted devices are made of titanium, therefore, it remains unknown what is causing the itching.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.

• Brand Name: MINI TRAY STD TI +6 OFFSET
• Common Device Name: PROSTHESIS, EXTREMITY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11457024
• Report Number: 0001822565-2021-00662
• Device Sequence Number: 3632101
• Product Code: PHX
• UDI-Device Identifier: 00887868231469
• UDI-Public: (01)00887868231469(17)290331(10)64352530
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/04/2021

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: 110031414
• Device Lot Number: 64352530
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 04/08/2021; 06/03/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 04/09/2021; 06/04/2021
• 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: Other
• Patient Weight: 82