MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP SRS LR REV PRX BDY IMPACT; SHOULDER JOINT METAL/POLYMER NON-CONSTRAINED CEMENTED PROSTHESIS

Catalog Number 405231

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4) d10: associated product information, part number (lot number): ¿ 414925 (258820) ¿ 405166 (694380) zimmer biomet has received the product and the investigation is in process.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 Description

It was reported that during an initial procedure, the segmental impactor tip cracked inside the handle.The correct surgical technique was used.No complications, injuries, surgical interventions, or foreign bodies were retained due to this malfunction.It was reported that no further information is available.

• Brand Name: COMP SRS LR REV PRX BDY IMPACT
• Type of Device: SHOULDER JOINT METAL/POLYMER NON-CONSTRAINED CEMENTED PROSTHESIS
• 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: 18685702
• MDR Text Key: 335196092
• Report Number: 0001825034-2024-00321
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 405231
• Device Lot Number: 116580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/27/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: H10
• Patient Sex: Prefer Not To Disclose