MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMP RVRS SHLDR GLNSP STD 36MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: comp rvrs shdr glen bsplt +ha part # 115330 lot # 629650.Comp primary stem 8mm std part # 113648 lot # 985870.Comp rvs hmrl ti tray 44mm part # 115340 lot # 228430.Arcom xl 44-36 std hmrl brng part # xl-115363 lot # 853780.Versa-dial/comp ti std taper pr adaptor part # 118001 lot # 362020.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 06871, 0001825034 - 2017 - 06872, 0001825034 - 2017 - 06873, 0001825034 - 2017 - 06875, 0001825034 - 2017 - 06876.It is unknown if the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It is reported that the patient received a comprehensive reverse shoulder 5 1/2 years ago.It has been further reported that the patient is being considered for a revision due to unknown reasons.  attempts have been to find more information made but no more information is available at this time.

Manufacturer Narrative

(b)(4).

• Brand Name: COMP RVRS SHLDR GLNSP STD 36MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6828572
• MDR Text Key: 83934918
• Report Number: 0001825034-2017-06874
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 115310
• Device Lot Number: 239030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2017
• Initial Date FDA Received: 08/29/2017
• Supplement Dates Manufacturer Received: 01/30/2018
• Supplement Dates FDA Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR