MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN BASEPLATE; PROSTHESIS, EXTREMITY

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Tingling (2171); Sleep Dysfunction (2517)

Event Date 10/14/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr's were reported for this event.Please also see associated events: 0001825034-2018-01206; 0001825034-2018-01207; 0001825034 - 2018 - 03437 ; 0001825034 - 2018 - 03439.Medical devices: 211220 compr srs prox bdy lot 294130; 211264 compr srs mod stem lot 879230; cp562105 cust rev glenoid lot 845370; unknown part/lot, central screw; unknown part/lot, central screw; this report is being submitted late as it has been identified in remediation.Report source: foreign.The event occurred in (b)(6).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.Device remains implanted.

Event Description

It was reported as part of clinical study 540 that a patient underwent a right shoulder revision procedure.Subsequently, during 1 &3 year follow up appointment, the patient reported severe pain and tingling, so much difficulty that couldn¿t sleep.Also being unable to do the following; open a jar, to do heavy chores, to carry a bag, to wash back, to cut, and to do recreational activities and interfered with social activities and daily activities.

• Brand Name: UNKNOWN BASEPLATE
• Type of Device: PROSTHESIS, EXTREMITY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7525580
• MDR Text Key: 108638838
• Report Number: 0001825034-2018-03438
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2014
• Initial Date FDA Received: 05/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 105