MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN COMPREHENSIVE REVERSE SHOULDER; SHOULDER, PROSTHESIS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign: (b)(6).Inoue, kazuya, et al."humeral bone resorption after reverse shoulder arthroplasty using." jses international, vol.4, 2020, pp.138-43, doi:https://doi.Org/10.1016/j.Jses.2019.11.007.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.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

A journal article was retrieved from jses international (2020) that reported a study from japan that looked at the prevalence and risk factors of humeral bone resorption.The purpose of the study was to investigate the prevalence of humeral bone resorption after reverse shoulder arthroplasty procedures and to evaluate the risk factors for bone resorption.The study reviewed 48 reverse total shoulder arthroplasty patients with an uncemented humeral stem.The trabecular metal reverse shoulder system was used in 22 shoulders (zimmer); comprehensive reverse shoulder system, 11 (biomet); smr system, 10 (lima); and delta extend reverse shoulder system, 5 (depuy).The indication for arthroplasty was intractable pain and functional disability due to cuff tear arthropathy in 39 shoulders, retear after cuff repair in 4, malunion after proximal humeral fractures in 2, primary osteoarthritis in 2, and conversion from humeral head replacement in 1.The study population had a mean age of 76.5 years at time of surgery (range 70-88 years).A mean length of follow-up was conducted for 18.5 months (range 12-31 months).The study reported bone resorption of grade 4 or higher occurred in 6 shoulders with the comprehensive reverse shoulder system; one of which was a (b)(6) year-old female who received an onlay-type implant with latissimus dorsi transfer for cuff tear arthropathy.The patient exhibited bone resorption in zones 1, 2, and 7 at six months postop that progressed to grade 4 resorption at 1 year postop.

• Brand Name: UNKNOWN COMPREHENSIVE REVERSE SHOULDER
• Type of Device: SHOULDER, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11285457
• MDR Text Key: 233813055
• Report Number: 0001825034-2021-00372
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other