MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 12MM ÿ 130MM LENGTH HUMERAL STEM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	00434901213
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Osteopenia/ Osteoporosis (2651); Subluxation (4525)
Date of Event	10/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event; please see the associated reports: 0001822565 - 2023 - 02991.D10: concomitant medical products - part number (lot number): 00434901213 (63700625).Associated product information: 00434901500 (63715593).00434904011 (63653808).01.04223.036 (2921546).01.04223.036 (2921529).G2: foreign - event occurred in denmark.The customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that 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 underwent a previously reported reverse arthroplasty revision surgery one (1) year and ten (10) months ago due to the poly component disassociating from the stem.Subsequently, the patient underwent a second revision approximately one (1) week ago due to the poly component disassociating from the stem and partial subluxation.The poly was removed and replaced with a spacer and a retentive liner.No other patient consequences were reported as a result of the event.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: proposed component code - mechanical (g04)- stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: a reverse-type left shoulder arthroplasty has been performed.There is no fracture or implant loosening.There is malalignment of the glenosphere-humeral articulation consistent with polyethylene fracture, wear or displacement.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report 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: 12MM ÿ 130MM LENGTH HUMERAL STEM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 18118653
• Report Number: 0001822565-2023-02991
• Device Sequence Number: 6884153
• Product Code: PHX
• UDI-Device Identifier: 00889024268951
• UDI-Public: (01)00889024268951(17)270831(10)63700625
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K130661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 02/20/2024

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 Catalogue Number: 00434901213
• Device Lot Number: 63700625
• 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: 10/18/2023
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 117 KG