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

Model Number N/A

Device Problems Failure to Align (2522); Migration (4003)

Patient Problem Pain (1994)

Event Date 06/27/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Unique identifier (udi) #: n/a.Concomitant medical products: unknown glenosphere.Unknown humeral stem unknown humeral bearing.Unknown glenoid baseplate.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-01775.

Event Description

It has been reported that approximately 3 months post implantation, the patient has had complaints of pain and alignment issues of the devices in the l shoulder.The patient indicates that the shoulder seems to pop out, and surgeon tells him that devices are coming out of alignment.There has been suggestion of surgical intervention, but none to date.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Product code - phx.Concomitant medical products: comp rvrs 25mm bsplt ha+adptr catalog # 010000589 lot # 193550 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 comp rvs tray +5mm co 44mm catalog # 115375 lot # 350670 bearing e1 humrl std 44-41mm catalog # ep115396 lot # 429540.

Event Description

It was further reported through patient's operative reports that the patient experienced subluxation approximately two months post-implantation.The patient was treated with home therapy exercises.The patient visited the emergency room approximately three months post-implantation due to pain and alleged dislocation; however, hospital staff confirmed the prosthesis was in the correct position and no dislocation was present.Patient was placed in an arm sling.Further, approximately six months post-implantation the patient had four episodes of subluxation and was prescribed at home exercise therapy.

Manufacturer Narrative

Upon receipt of information received and reassessment of the reported event, it was determined that this device was not related to the event.

Event Description

Upon receipt of information received and reassessment of the reported event, it was determined that this device was not related to the event.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

From additional information received, the patient was revised.The patient further alleged unknown components were noted to be loose during the revision procedure.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8560320
• MDR Text Key: 143402065
• Report Number: 0001825034-2019-01776
• Device Sequence Number: 1
• Product Code: KWS
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• 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: 115320
• Device Lot Number: 352060
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 108