MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MINI TRAY STD COCR +3 OFFSET; PROSTHESIS SHOULDER

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical product: catalog #: 110030777, cr 40mm glenosphere +3mm cocr, lot # 64492561; catalog #: 110031421, cr prolong 40mm brng std, lot # 64489322; catalog #: 110031402, mini tray std cocr +3 offset, lot # 64666175.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001822565-2020-03970 and 0001822565-2020-04059.Will be returned.
Event or Problem Description
It was reported the patient underwent a reverse tsa approximately two (2) months ago.Subsequent dislocation while trying to take out the trash sent him to the er and a closed reduction was performed.The doctor thought the poly bearing had disassociated from the humeral tray.The patient underwent a revision surgery and upon opening the wound during revision, it was discovered the poly had indeed disassociated from the humeral tray.The baseplate and stem stayed, the humeral tray and glenosphere were revised.
Additional Manufacturer Narrative
Cmp (b)(4) updated medical product: catalog #: 118000-00, 25mm versa-dial taper adaptor, lot # 068500 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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Reported event was confirmed as visual examination of the returned products identified them as being severely worn and gouged.No conclusions can be made regarding the disassociation reported as it was confirmed the bearing was reattached to the tray after explanting.A picture was provided showing the explanted bearing not attached to the tray, however, no other observations could be made.The cause of the gouges and wear noted on the bearing and glenosphere remains unknown as it is unknown if it happened intraoperative, in-vivo, post/pre disassociation, or during explanting.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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.

• Brand Name: MINI TRAY STD COCR +3 OFFSET
• Common Device Name: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11003418
• Report Number: 0001822565-2020-04060
• Device Sequence Number: 3486856
• Product Code: KWS
• UDI-Device Identifier: 00887868231346
• UDI-Public: 00887868231346
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110031402
• Device Lot Number: 64666175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 12/01/2020; 04/27/2021
• Initial Report FDA Received Date: 12/14/2020
• Supplement Report FDA Received Date: 12/17/2020; 04/29/2021
• 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: Hospitalization; Required Intervention