MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS HMRL TI TRAY 44MM; PROSTHESIS, SHOULDER

Catalog Number 115340

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 06/02/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Xl-115363 arcom xl 44-36 std hmrl brng 138490.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 mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 -01780.

Event Description

It was reported that the patient was revised due to instability, pain, and loosening of the implants of the right shoulder.The patient also had a clicking-like sensation.During the revision procedure, the surgeon noted the cone was found to be fractured.The surgeon found it difficult to remove the fractured cone, resulting in a procedure delay of about 120 minutes.Surgeon further noted, excessive poly wear on the medial rim of the humeral bearing.The surgeon removed the humeral stem by osteotomy and replaced with a cph revision stem.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned products identified the center post of the humeral tray was fractured and not returned.The tray also had scratches and gouges.The humeral bearing had scratches, gouges, and was worn on the edge.There were also small metal fragments in the humeral bearing.The humeral tray was submitted for further analysis.The fracture surface had significant smearing and a type of fracture was unable to be determined.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the reverse shoulder arthroplasty is anatomically aligned with no lucencies or complicating factors.Review of the device history records identified no deviations or anomalies during manufacturing.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 Description

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

• Brand Name: COMP RVS HMRL TI TRAY 44MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12011058
• MDR Text Key: 256563802
• Report Number: 0001825034-2021-01779
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 115340
• Device Lot Number: 526330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 75