MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS SHLDR GLNSP STD 36MM; 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).Concomitant medical products: part # 113627 lot # 292310 comp primary stem 7mm mini, part # 110005273 lot # 184150 comp cnv glen base non ha, part # xl-115363 lot # 588250 or 145510 arcom xl 44-36 std hmrl brng, 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 - 00922, 0001825034 - 2019 - 00923, 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.

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.

Event Description

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

• Brand Name: COMP RVRS SHLDR GLNSP STD 36MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8382196
• MDR Text Key: 137542695
• Report Number: 0001825034-2019-00921
• 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 Model Number: N/A
• Device Catalogue Number: 115310
• Device Lot Number: 990660
• 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