MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL 42X18X46 HUM HEAD; SHOULDER PROSTHESIS, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED / EXTREMITIES

Model Number 113032

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

T 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, 0001825034-2022-01974.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#: 118001, versa-dial/comp ti std taper; lot#: 926330.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.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6: component code- mechanical(g04) -head.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.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.

• Brand Name: VERSA-DIAL 42X18X46 HUM HEAD
• 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: 15310372
• MDR Text Key: 298775527
• Report Number: 0001825034-2022-01973
• Device Sequence Number: 1
• Product Code: MBF
• UDI-Device Identifier: 00880304212206
• UDI-Public: (01)00880304212206(17)280923(10)306460
• 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: 09/27/2022

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: 113032
• Device Catalogue Number: 113032
• Device Lot Number: 306460
• 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: 09/23/2018
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female