MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 11MM MINI; PROSTHESIS, SHOULDER

Catalog Number 113631

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: sm hybrid glenoid base 4mm cat# 113952 lot# 999610; versa-dial/comp ti std taper cat# 118001 lot# 558060; versa-dial 38x19x39 hum head cat# 113022 lot# 314040; pt hybrid glen post regenerex cat# pt-113950 lot# 478220; biomet bc r 1x40 us cat# 110035368 lot# 825baf1806.The event was initially reported on 0001822565-2020-03512.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 04240, 0001825034 - 2020 - 04241, 0001825034 - 2020 - 04242, 0001825034 - 2020 - 04243.

Event Description

It was reported patient alleges experiencing pain and the device moves out of place approximately one year post implantation.Patient alleges the devices move around in ways they are not supposed to.No revision has been reported to date.Attempts to obtain additional information have been made; however, no more is available at this time.

Manufacturer Narrative

Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: -surgery encountered hemorrhage underneath the deltoid and old clots which were removed.1 day postop- discharge ¿ hemovac drain removed, x-ray post-op stable, rto 10 days for suture removal.8 months postop- post right shoulder total shoulder from comminuted fracture, and physical therapy, weakness and inability to abduct shoulder.Arthrogram performed positive for possible rotator cuff tear.Open exploration of rotator cuff under block and general anesthesia.Definitive hole in supraspinatus 1/4in in diameter.Supraspinatus was intact, but was poorly attached to lateral cortices of humerus.Adhesions/scar tissue released, and reinforcement of supraspinatus performed.No complications, placed in immobilizer.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 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

No further event information at the time of this report.

• Brand Name: COMP PRIMARY STEM 11MM MINI
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10958590
• MDR Text Key: 219880764
• Report Number: 0001825034-2020-04239
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: K060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 113631
• Device Lot Number: 830090
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Other
• Patient Weight: 77