MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ARCOM XL 44-36 STD HMRL BRNG; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Unstable (1667); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 08/03/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: comp rvrs shdr glen bsplt +ha part # 115330 lot # 629650, comp primary stem 8 mm std part # 113648 lot # 985870, comp rvs hmrl ti tray 44 mm part # 115340 lot # 228430, comp rvrs shldr glnsp std 36 mm part # 115310 lot # 239030, 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 - 06874, 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).This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which 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 is reported that the patient underwent revision surgery 5 1/2 years post initial surgery dur to instability.Attempts have been to find more information made but no more information is available at this time.

• Brand Name: ARCOM XL 44-36 STD HMRL BRNG
• 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: 6828575
• MDR Text Key: 83949164
• Report Number: 0001825034-2017-06875
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2018

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/28/2016
• Device Model Number: N/A
• Device Catalogue Number: XL-115363
• Device Lot Number: 853780
• 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; 02/21/2018
• Supplement Dates FDA Received: 02/20/2018; 03/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2011
• 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