MAUDE Adverse Event Report: ZIMMER BIOMET, INC. POLY LINER PLUS 0 MM OFFSET 36 MM DIAMETER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Joint Dislocation (2374); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown glenoid, unknown; unknown stem, unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-03308, 0001822565-2019-03310.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient's right shoulder is to be revised on an unknown date due to an unknown reason.Attempts were made to gain information, however no additional information was made available.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.X-rays were provided and reviewed, however, the hardware appeared to be intact.Device history record (dhr) was reviewed and no discrepancies were found.It was reported that the patient had used the arm to lift himself and resulted in the dislocation.The root cause of the reported issue is attributed to patient noncompliance.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

It was reported that the patient's right shoulder is indicated for revision due to multiple dislocations.Surgery not scheduled yet.No additional information is available from the event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.Concomitant medical products : 110032430, comp aug mini bsplt w tpr lg, 64115028, 00434903909, humeral stem spacer size 9, 64015697, 00434901413, humeral stem 14 mm stem diameter 130 mm stem length, 63936078, 115316, comp rvrs shldr glnsp +6 36mm, 946590.

• Brand Name: POLY LINER PLUS 0 MM OFFSET 36 MM DIAMETER
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8861305
• MDR Text Key: 153280669
• Report Number: 0001825034-2019-03422
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K052906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• 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: 00434903600
• Device Lot Number: 64008402
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 136