MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E1 44-41 STD +3 HMRL BRG; PROSTHESIS, SHOULDER

Model Number	EP-115397
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Subluxation (4525)
Date of Event	07/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: foreign- (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.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 - 2022 - 00156.
Event or Problem Description
It was reported that the patient underwent revision surgery approximately five months post initial due to luxation on his left shoulder.New comprehensive srs reverse components were implanted.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h6, h10 reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.
Event or Problem Description
No additional event information is available at the time of this report.
Additional Manufacturer Narrative
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.
Event or Problem Description
No additional event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the previous investigation not does not change.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 additional event information is available at the time of this report.

• Brand Name: E1 44-41 STD +3 HMRL BRG
• 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: 13346215
• Report Number: 0001825034-2022-00157
• Device Sequence Number: 1674886
• Product Code: KWS
• UDI-Device Identifier: 00880304543171
• UDI-Public: (01)00880304543171(17)221222(10)427750
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K113121
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/09/2022
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 12/22/2022
• Device Model Number: EP-115397
• Device Catalogue Number: EP-115397
• Device Lot Number: 427750
• 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: 01/12/2022
• Supplement Date Received by Manufacturer: 03/16/2022; 07/06/2022; 08/01/2022
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 03/24/2022; 07/21/2022; 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2017
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TI-115326 529100 COMP VRSDL GLNSPR 41MM +6 TI; UNK GLENOSPHERE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male