MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL GLENOID COMPONENT 52 MM ARTICULAR SURFACE; PROSTHESIS, SHOULDER

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	09/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).No product was returned; visual and dimensional evaluations could not be performed.No photographs of the articular surface were provided.The device history records were reviewed for deviations and/or anomalies with no anomalies/deviations related to the event identified.The sterile certificate was reviewed and noted to be conforming.It was sterilized in accordance with fda regulations and iso standards.The reported products were reviewed for compatibility with no issues noted.Review of complaint history found no additional related issues for the reported part and lot combination.X-ray images were reviewed with the following noted: extensive osteolysis involving both the humeral and glenoid implants with suspected implant loosening but no implant displacement or dislocation.The glenoid implant appears subsided.The root cause of the infection was determined to be unrelated to the implanted zimmer biomet device.The complaint for loosening is not confirmed.A definitive root cause (loosening) cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.Additional associated products 0104555130 humeral anchor uncemented l, lot#: 2922197; 00430005230 modular humeral head 30 mm head height 52 mm spherical head diameter, lot#: 61194309.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 the patient's shoulder was revised due to loosening.

• Brand Name: TRABECULAR METAL GLENOID COMPONENT 52 MM ARTICULAR SURFACE
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16335334
• Report Number: 3005751028-2023-00002
• Device Sequence Number: 6431299
• Product Code: KWS
• UDI-Device Identifier: 00889024306684
• UDI-Public: (01)00889024306684(17)230228(10)63924825
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K071090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/08/2023

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: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 00432605200
• Device Lot Number: 63924825
• 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: 09/06/2022
• Initial Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2018
• 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
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male