MAUDE Adverse Event Report: ZIMMER BIOMET, INC. +3MM THICKNESS 36MM DIAMETER BEARING; COMP REV SHOULDER SYSTEM PROLONG HIGHLY CROSSLINKED POLYETHYLENE BEARING +3MM

Catalog Number 110031419

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 03/27/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: medical prodcuts: item#: 00436003600, glenosphere centric 36 mm diameter +0 mm lateral offset, lot#: 66323916.Item#: sahtnem6, -6mm extended neutral humeral tray, lot#: 66046381.H3: product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial shoulder reverse shoulder arthroplasty approximately two (2) and a half months ago.The patient was doing great two (2) months post op having no pain and full elevation when the patient reached for a coat in a car and felt a sudden pain and clicking sensation in their shoulder.Subsequently, the surgeon scheduled the patient for a revision of the reverse identity stem.During the revision, it was discovered by the surgeon that the implant was no longer engaged.The implant was free floating in the shoulder joint.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Device was not returned.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: single ap view of the right shoulder dated 3/28/24 demonstrates narrowing of the glenohumeral joint with metal-on-metal appearance suggesting polyethylene spacer dislocation, with radiolucent spacer possibly within the subacromial sub deltoid space.A definitive root cause cannot be determined.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: +3MM THICKNESS 36MM DIAMETER BEARING
• Type of Device: COMP REV SHOULDER SYSTEM PROLONG HIGHLY CROSSLINKED POLYETHYLENE BEARING +3MM
• 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: 19172303
• MDR Text Key: 340914738
• Report Number: 0001822565-2024-01386
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00887868231506
• UDI-Public: (01)00887868231506(17)270905(10)65381485
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181611
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110031419
• Device Lot Number: 65381485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 69 YR