MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR SRS MOD STEM - 6X150MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Date 07/28/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4) multiple mdr's were reported for this event.Please also see associated events: 0001825034-2018- 01568.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event 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.Not returned to manufacturer.

Event Description

It was reported the patient had mild pain, being unable to do the following; open jar, do heavy chores, to carry bag, to wash back, and to do recreational activities.Also severely difficult to cut, interfered with social activities, very limited in daily activities, and so much difficulty that couldn¿t sleep.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Upon reassessment, it was determined this device should not have been reported in relation to this event.Please void this submission.

• Brand Name: COMPR SRS MOD STEM - 6X150MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7377006
• MDR Text Key: 103671118
• Report Number: 0001825034-2018-01569
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: PK111746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 211241
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: THE 211218 COMPR SRS PROX BDY - LG 42MM, LOT UNKNOWN; THE 211218 COMPR SRS PROX BDY - LG 42MM, LOT UNKNOWN
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 53