MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR RVS BSPLT RMR 25MM SHORT; SHOULDER INSTRUMENT

Catalog Number 110029136

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Bone Fracture(s) (1870)

Event Date 06/24/2022

Event Type  Injury  

Event Description

It was reported that during an initial implantation, the surgeon fractured the anterior cortex of the patient's glenoid while reaming.Subsequently, the surgeon opted to leave the patient's joint loose in order to allow the bone to heal with the intention of revising the patient at a later time to re-tension the shoulder.Approximately fifteen (15) days post-fracture, the surgeon performed an additional procedure on the patient and a new glenosphere and humeral polyethylene were implanted.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Fda product code - phx.Concomitant medical products: item# 110031399; lot# 65255109; item# 110030776; lot# 65323728; item# 110031428; lot# 65163940; item# 20809000402; lot# 65351090; item# 110032420; lot# 65212354.Foreign - event occurred in australia.The event was initially reported on 0001825034-2022-02317.However, after further information from the contact a new medwatch was necessary for the event.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product continues to be used in other procedures.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6; h10 h6: proposed annex g code: mechanical (g04) - drill no product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was unable to be performed as the lot number of the device involved in the event is unknown.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right shoulder reverse-type arthroplasty components are anatomically aligned.There is no fracture or dislocation.Bone quality is osteopenic.A definitive root cause cannot be determined.If any further information is found 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 Description

No further event information available at the time of this report.

• Brand Name: COMPR RVS BSPLT RMR 25MM SHORT
• Type of Device: SHOULDER INSTRUMENT
• 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: 15638977
• MDR Text Key: 302086479
• Report Number: 0001825034-2022-02378
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 110029136
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female