MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP AUG MINI BSPLT W TPR MD; SHOULDER, PROSTHESIS

Model Number	110032420
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant products: comp rvs tray co 44mm cat: 115370 lot: unknown; arcom xl 44-36 std hmrl brng 36mm cat: xl-115363 lot: 874890; comp rvrs shldr glnsp std 36mm cat: 115310 lot: 502220.Report source: foreign: (b)(6).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 report will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-00445, 0001825034-2022-00446, 0001825034-2022-00447.Product not returned.
Event or Problem Description
It was reported that the patient was revised approximately 1 year and 2 days post implantation due to a foreign object identified on post op radiographs.The object was removed and all components were removed and replaced.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.
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.Not reportable.- the returned fragment does not match any of the returned implants.This event will be reported under medwatch: 0001825034-2022-01296.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
This follow-up report is being submitted to relay additional information.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
It was reported that the patient was revised approximately 1 year and 2 days post implantation due to a foreign object identified on post op radiographs.The object was removed and all components were removed and replaced.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: comp rvs tray co 44mm cat: 115370 lot: unknown arcom xl 44-36 std hmrl brng 36mm cat: xl-115363 lot: 874890 comp rvrs shldr glnsp std 36mm cat: 115310 lot: 502220 foreign: united kingdom.This product was determined to be possibly involved as the foreign body was determined to be a titanium alloy.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 : product not returned.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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
It was reported that the patient was revised approximately 1 year and 2 days post implantation due to a foreign object identified on post op radiographs.The object was removed and the humeral tray, humeral bearing , glenosphere and mini taper adapter were all exchanged for new implants.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g7, h1, h2, h6, h10.Visual examination of the returned product identified an unknown black object (2 pieces) was returned; it was not generated from the other returned and/or reported products as the color does not match that of the reported products, and cosmetic inspection of the returned products found only light scratches and wear marks.The unknown foreign body was sent to sem for further analysis: eds semi-quantitative elemental analysis of an unknown wire sample showed that the composition was consistent with ti-6al-4v material, along with o, c, p, and s.The wire appeared to be heavily oxidized and contaminated with carbon, phosphorous and sulfur.Device history record was reviewed and no discrepancies were found.It is possible that the unknown foreign body was generated during insertion of the screws into the baseplate, however this cannot be confirmed.Additionally, it is unknown which product it was possibly generated from.It remains that 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.

• Brand Name: COMP AUG MINI BSPLT W TPR MD
• Common Device Name: SHOULDER, PROSTHESIS
• 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: 13653262
• Report Number: 0001825034-2022-00448
• Device Sequence Number: 11355284
• Product Code: KWS
• UDI-Device Identifier: 00880304993242
• UDI-Public: (01)00880304993242(17)240213(10)64298726
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K172502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup,Followup,Followup
• Report Date (Section B): 11/22/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/13/2024
• Device Model Number: 110032420
• Device Catalogue Number: 110032420
• Device Lot Number: 64298726
• 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: 02/17/2022
• Supplement Date Received by Manufacturer: 05/04/2022; 09/07/2022; 09/07/2022; 10/17/2022; 11/18/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 05/26/2022; 09/07/2022; 09/07/2022; 10/18/2022; 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2019
• 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; SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female