MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOM XL 44-41 RTNV +3 HMRL BR; SHOULDER, PROSTHESIS

Catalog Number	XL-115368
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was revised approximately two weeks post implantation due to dislocation.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: d10: comp rvrs shldr glnsp std 41mm cat: 115320 lot: 540470.Comp rvs tray co 44mm cat: 115370 lot: 65783131.G2: foreign: united kingdom.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.H3 other text : product not returned.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified showed slight wear on the bearing.The articulating radius of the glenosphere is slightly smaller than the articulating radius of the humeral bearing to allow for articulation without edge loading.The trial and implant dimensioning are the same but there is a very slight difference to prevent the glenosphere from extending over the rim of the humeral bearing to reduce the likelihood of edge loading occurring.Device history record was reviewed and no discrepancies were found.The reported event is not confirmed.A definitive root cause cannot be determined.A summary of the investigation has been sent to the complainant.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
This follow-up report is being submitted to relay additional information.The following sections were.Visual examination of the returned product identified the measured features f1 and f2 of the glenosphere and both were conforming.The glenosphere does show signs of use with scratches on the polished surface.No measurements were taken of the poly bearing as the bearing did not sit flush on the tray; however, it was seated in the tray, and the device was autoclaved per the per.There are areas where daylight can be seen between the bearing and the tray.The additional information provided does not change the root cause of the previous investigation.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: ARCOM XL 44-41 RTNV +3 HMRL BR
• Common Device Name: SHOULDER, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17595254
• Report Number: 0001825034-2023-01965
• Device Sequence Number: 17749847
• Product Code: KWS
• UDI-Device Identifier: 00880304475830
• UDI-Public: (01)00880304475830(17)240422(10)912820
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 01/11/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/22/2024
• Device Catalogue Number: XL-115368
• Device Lot Number: 912820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/25/2023
• Supplement Date Received by Manufacturer: 10/11/2023; 01/09/2024
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 10/25/2023; 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2019
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown