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

Model Number N/A

Device Problem Insufficient Information (3190)

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

Event Date 09/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product code: phx.Two humeral bearings were reported were reported in conjunction with this event.It is unknown which device was used in the 2nd revision surgery.The information for the 2nd tray is as follows: catalog number: xl-115363, catalog number: 145510, expiration date: jun 19, 2022, manufacture date: : jun 19, 2017, (b)(4).Concomitant medical products: part # 113627, lot # 292310, comp primary stem 7mm mini; part # 115310, lot # 990660, comp rvrs shldr glnsp std 36mm; part # 110005273, lot # 184150, comp cnv glen base non ha; part # 115375, lot # 822460 or 272100, comp rvs tray co 44mm; part # 115395, lot # 650420, comp rvs cntrl 6.5x25mm st/rst; part # 180551, lot # 969080, comp lk scr 3.5hex 4.75x20 st; part # 180552, lot # 715590, comp lk scr 3.5hex 4.75x25 st; part # 405883, lot # 538650, comp rvs 3.2mm drl; part # 405800, lot # 905620, comp.Rev shldr 9 in steinmann; part # 405889, lot # 538820, comp rvs 2.7mm dia drl; part # 110005237, lot # 509950, comp conv glen liner e1; part # 118001, lot # 120880, versa-dial/comp ti std taper.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2019 -00920, 0001825034 -2019 -00921, 0001825034 -2019 -00922, 0001825034 -2019 -00924, 0001825034 -2019 -00925, 0001825034 -2019 -00926.Not returned to manufacturer.

Event Description

It has been reported that patient is suffering from chronic pain and non functioning joint (9) nine months post revision surgery.Patient is undergoing seeking care under a pain management specialist.No additional patient consequences were reported.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.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.

• Brand Name: ARCOM XL 44-36 STD HMRL BRNG
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8382194
• MDR Text Key: 137542322
• Report Number: 0001825034-2019-00923
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: XL-115363
• Device Lot Number: 588250
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2019
• Initial Date FDA Received: 03/01/2019
• Supplement Dates Manufacturer Received: 05/29/2019
• Supplement Dates FDA Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 56 YR
• Patient Weight: 68