MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY; PROSTHESIS SHOULDER

Model Number N/A

Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Joint Dislocation (2374); No Information (3190)

Event Date 06/27/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4), udi #: (b)(4).Concomitant medical products: comprehensive reverse shoulder bearing catalog # ep115361 lot # 429540.Comprehensive reverse shoulder glenosphere mini baseplate with taper adapter catalog # 010000589 lot # 193550, comp rvrs shldr glnsp std 41mm catalog # 115320 lot # 352060 , comp rvs cntrl 6.5x45mm st/rst catalog # 115399 lot # 57347, comp lk scr 3.5hex 4.75x35 st catalog # 180554 lot # 700070, comp lk scr 3.5hex 4.75x35 st catalog # 180554 lot # 466990 , comp lk scr 3.5hex 4.75x20 st catalog # 180551 lot # 993730, comp lk scr 3.5hex 4.75x20 st catalog # 180551 lot # 807940 , comp primary stem 16mm mini catalog # 113636 lot # 882800.Customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034-2019-04116.Product location is unknown.

Event Description

It was reported patient underwent a revision procedure approximately eight months post-implantation due to inadequate tension in the joint.Patient reported dissatisfaction and pain with recurrent episodes of subluxation.

Event Description

It was further reported through patient¿s medical records that prior to the revision procedure, the patient underwent home therapy to try and resolve the reported adverse events.However, this was unsuccessful and therefore, the revision procedure was performed.The bearing and tray were removed and replaced.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Udi # (b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event 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: COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY
• Type of Device: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9071804
• MDR Text Key: 158735331
• Report Number: 0001825034-2019-04115
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K113069
• 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: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 115375
• Device Lot Number: 350670
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 108