MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS SHLDR GLNSP STD; PROSTHESIS, SHOULDER

Catalog Number 115310

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

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 05/04/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Common device name: phx.Concomitant medical devices: comp primary stem 7mm mini cat# 113627, lot# 534700; comp aug mini bsplt w tpr sm cat# 110032410, lot# 64314041; comp rvs cntrl 6.5x20mm st/rst cat# 115394, lot# 585860; comp lk scr 3.5hex 4.75x15 st cat# 180550, lot# 351840; comp lk scr 3.5hex 4.75x15 st cat# 180550, lot# 351840; comp lk scr 3.5hex 4.75x25 st cat# 180552, lot# 628410; comp lk scr 3.5hex 4.75x20 st cat# 180551, lot# 628250; mini humeral tray standard thickness +0 mm taper offset 40 mm diameter cat# 110031399, lot# 64314393; bearing standard 36 mm diameter cat# 110031418, lot# 64299809.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 - 02050, 0001825034 - 2020 - 02052, 0001825034 - 2020 - 02053, 0001825034 - 2020 - 02054, 0001825034 - 2020 - 02055, 0001825034 - 2020 - 02056, 0001825034 - 2020 - 02057.

Event Description

It was reported a patient had an initial right reverse tsa.Subsequently, at the one-year visit, the patient was experiencing pain and decrease in activities of daily living when compared to the 6-month visit.Activities of daily living which have decreased include the following: unable to do light house work, throw a ball overhand, lift 10 lbs.Overhead, very difficult to put on a coat, sleep on affected side, and/or reach a high shelf.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: d4: udi # - (b)(4), (b)(4), (b)(4).Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: mild to moderate pain (4.6).Decrease in activities of daily living and very difficult to put on a coat, sleep on affected side, or reach a high shelf.At 6 month follow-up, patient had a 27.4 decrease in ases patient self-evaluation.Shoulder feels very stable.Good rom.No significant radiographic findings.Review of the device history records identified no related deviations or anomalies during manufacturing.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.

• Brand Name: COMP RVRS SHLDR GLNSP STD
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10071643
• MDR Text Key: 193936606
• Report Number: 0001825034-2020-02051
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• PMA/PMN Number: K080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 115310
• Device Lot Number: 403190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Other
• Patient Weight: 71