MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOM XL 44-36 STD HUMERAL BEARING; PROSTHESIS, SHOULDER

Catalog Number XL-115363

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 06/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: comp rvs hmrl ti tray 44mm cat# 115340 lot# 848190, comp rvrs shdr glen bsplt +ha cat# 115330 lot# 680590, comp rvs cntrl scr 6.5x30mm st cat# 115382 lot# 468480, comp locking screw 4.75x25mm cat# 180502 lot# 436160, comp locking screw 4.75x20mm cat# 180501 lot# 792810, comp locking screw 4.75x20mm cat# 180501 lot# 851360, comp locking screw 4.75x25mm cat# 180502 lot# 402210, versa-dial/comp ti std taper cat# 118001 lot# 879070.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: 0001825034-2018-03378.

Event Description

It was reported that a patient underwent an initial procedure.Approximately 7 years later, patient used arm to help get up from seated position and felt a pop.Patient was revised approximately 8 months later due to pain and loss of range of motion.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Upon reassessment of the reported event, the bearing was determined to be not reportable.The initial report was forwarded in error and should be voided.

Event Description

Upon reassessment of the reported event, the bearing was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: ARCOM XL 44-36 STD HUMERAL BEARING
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10143741
• MDR Text Key: 195518986
• Report Number: 0001825034-2020-02326
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• PMA/PMN Number: K080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2014
• Device Catalogue Number: XL-115363
• Device Lot Number: 582660
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention