MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL/COMP TI STD TAPER; SHOULDER PROSTHESIS, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED / EXTREMITIES

Model Number 118001

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 08/06/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent a right shoulder arthroplasty.Subsequently, the patient had revision surgery approximately one year and eight months after the initial surgery due to pain, loss of range of motion, and loosening of the implants.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01970; 0001825034-2022-01971; 0001825034-2022-01972; 0001825034-2022-01973.Concomitant medical products: item#: pt-113950, pt hybrid glen post regenerex; lot#: 607920; item#: 113952, sm hybrid glenoid base 4mm; lot#: 165380; item#: 113611, comp primary stem 11mm micro, lot#: 821310; item#: 113032, versa-dial 42x18x46 hum head; lot#: 306460.Device evaluated by mfr: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay corrected information.The following sections were updated: b4; b5; g3; g6; h1; h2 upon reassessment of the reported event, it was determined that this product was not reportable.The initial report was forwarded in error and should be voided.

Event Description

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

• Brand Name: VERSA-DIAL/COMP TI STD TAPER
• Type of Device: SHOULDER PROSTHESIS, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED / EXTREMITIES
• 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: 15310376
• MDR Text Key: 298774648
• Report Number: 0001825034-2022-01974
• Device Sequence Number: 1
• Product Code: MBF
• UDI-Device Identifier: 00880304217249
• UDI-Public: (01)00880304217249(17)281011(10)926330
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 118001
• Device Catalogue Number: 118001
• Device Lot Number: 926330
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2018
• 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 Sex: Female