MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING; PROSTHESIS SHOULDER

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Udi# (b)(4).Concomitant medical products: catalog #: 115310, comp rvrs shldr glnsp std, lot # 670930, catalog #: 115330, comp rvrs shdr glen bsplt, lot # 415440, catalog #: 113653, comp primary stem 13mm std, lot # 921870, catalog #: 118001, versa-dial/comp ti std taper, lot # 411920, catalog #: ep-115395, e1 44-36 rtnv +3 hmrl brg, lot # 386560, catalog #: 115378, comp rvs tray +10mm co 44mm, lot # 800090.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-04951, 0001825034-2019-04952, 0001825034-2019-04953, 0001825034-2019-04954, 0001825034-2019-04955, 0001825034-2019-04956, 0001825034-2019-04957.Remains implanted.
Event or Problem Description
It was reported that patient is still experiencing pain approximately two years post-implantation.No further information is available at this time.
Additional Manufacturer Narrative
(b)(4).Medical product: catalog #: 180561, comp nlk scr 3.5hex 4.75x35 st, lot # 251830 catalog #: 180552, comp lk scr 3.5hex 4.75x25 st, lot # 593030 catalog #: 180553, comp lk scr 3.5hex 4.75x30 st, lot # 472190 catalog #: 180560, comp nlk scr 3.5hex 4.75x30 st, lot # 541780 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.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-04986, 0001825034-2019-04987, 0001825034-2019-04988, 0001825034-2019-04991.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
It was reported that patient underwent left reverse total shoulder approximately 8 years ago.Subsequently about a year later the patient underwent revision due to bone erosion (notching) ho, and baseplate positioning.The patient retained well fixed stem and had the humeral tray & bearing revised.Glenosphere components revised to competitor products.Subsequently the patient reports of ongoing pain since the revision.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).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.
Additional Manufacturer Narrative
(b)(4).The reported event is not confirmed; however, review of the revision operative note and implant logs confirmed incompatible implants used (non-zimmer biomet implants).Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: patient underwent left reverse total shoulder about 10 years ago.Subsequently a month later underwent revision due to bone erosion (notching) ho, and baseplate positioning.Retained well fixed stem revised humeral tray & bearing.Glenosphere components revised to competitor products.Medical records related to ongoing pain were not provided.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined as it is unknown what is causing the reported pain.However, medical records provided state that the implants were used with competitor implants, which are not compatible.The use of incompatible implants is considered off-label use.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: COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING
• Common Device Name: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 9270704
• Report Number: 0001825034-2019-04952
• Device Sequence Number: 2131950
• Product Code: KWS
• UDI-Device Identifier: 00880304543133
• UDI-Public: (01)00880304543133(17)210603(10)386560
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K132239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/30/2024

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: 06/03/2021
• Device Model Number: N/A
• Device Catalogue Number: EP-115395
• Device Lot Number: 386560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 02/05/2020; 03/07/2024; 09/25/2024
• Initial Report FDA Received Date: 11/03/2019
• Supplement Report FDA Received Date: 02/10/2020; 04/04/2024; 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2016
• 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 NARRATIVE.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White