MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS SHLDR GLNSP +6 36MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00434903600, poly liner plus 0 mm offset 36 mm diameter, 64008402, 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.Customer has indicated that the product will not be returned to zimmer biomet for investigation, [ remains implanted ].The investigation is in process.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 indicated for revision approx 1 year post implantation continuous dislocation.The patient is non compliant.No further information has been provided.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.No devices or medical records were received.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

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

• Brand Name: COMP RVRS SHLDR GLNSP +6 36MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8910317
• MDR Text Key: 154869384
• Report Number: 0001825034-2019-03714
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: K120906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• 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: 115316
• Device Lot Number: 946590
• 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): Other
• Patient Weight: 136