MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM ÿ +6MM OFFSET POLY LINER; PROSTHESIS, SHOULDER

Model Number	00-4349-036-06
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a competitor anatomic shoulder revision.Subsequently, the patient revised the humeral side again as she subluxed post-surgery and was unstable.No additional patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: part: unknown glenoid head lot: unknown.Part: 00-4349-008-17 lot: 63041765 tm reverse stem 8mm x 170mm.Part: 00434903912 lot: 62278467 12mm humeral stem spacer.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.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: 0001822565 -2022 -01711.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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.H3 other text : not returned by hospital.
Event or Problem Description
No additional event information is available at the time of this report.

• Brand Name: 36MM ÿ +6MM OFFSET POLY LINER
• Common Device Name: PROSTHESIS, SHOULDER
• 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: 14643322
• Report Number: 0001822565-2022-01657
• Device Sequence Number: 4867441
• Product Code: KWS
• UDI-Device Identifier: 00889024633070
• UDI-Public: (01)00889024633070(17)260430(10)63842339
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K052906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2022

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 Expiration Date: 04/30/2026
• Device Model Number: 00-4349-036-06
• Device Catalogue Number: 00434903606
• Device Lot Number: 63842339
• 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: 05/14/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2018
• 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: SEE NARRATIVE IN H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 97 KG