MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMP RVS HMRL TI TRAY 44MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 07/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Therapy date - (b)(6) 2017.Concomitant medical product - comp primary stem 11mm mini catalog # 113631 lot # 211880.Arcom xl 44-41 rtnv +3 hmrl br catalog # xl-115368 lot # 968090.Versa-dial/comp ti std taper pr adaptor catalog # 118001 lot # 669020.Comp rvs cntrl scr 6.5x35mm st catalog # 115383 lot # 524300.Comp locking screw 4.75x15mm catalog # 180500 lot # 719980.Comp locking screw 4.75x20mm catalog # 180501 lot # 064010.Comp locking screw 4.75x30mm catalog # 180503 lot # 813750.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent right shoulder revision due to breakage of reverse titanium humeral tray.

Manufacturer Narrative

(b)(4).This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.

Event Description

It was reported that a patient underwent an initial right shoulder procedure.Subsequently, the patient was revised due to implant breakage.The broken part of the humeral tray was in the stem, and the surgeon removed the implant from patient.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Concomitant medical products: comp rvrs shldr glnsp std 41mm cat: 115320 lot: 555050.Comp rvrs shdr glen bsplt +ha cat: 115330 lot: 215060.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the tray revealed product identification was illegible, due to extreme scratching.The center of tray, where taper was previously, has a jagged edge revealing taper fracture.The broken tray taper remains lodged and/or embedded inside of stem which, as a result was removed.Sem results reveal post-fracture damage obfuscates many fracture artifacts and does not allow visual determination of fracture type.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.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 was reported that patient underwent right reverse total shoulder revision approximately six (6) years post-implantation due to fracture of reverse titanium humeral tray.As a result of the tray fracturing off into the humeral stem, the stem had to be removed from the patient.

• Brand Name: COMP RVS HMRL TI TRAY 44MM
• 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: 6837622
• MDR Text Key: 84873045
• Report Number: 0001825034-2017-06877
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 115340
• Device Lot Number: 459290
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2011
• Is the Device Single Use?: Yes
• 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: 70 YR
• Patient Weight: 93