MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR SRS PROX BDY - LG 42MM; ELBOW, PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

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

Event Date 05/05/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant product(s): a 211218, compr srs prox bdy - lg 42mm; unknown intercalary segment; unknown regenerex augment; unknown intramedullary stem; 211251, compr srs 60mm dst hml bdy lt; unknown pps augment; unknown seas head; report source, foreign - the event occurred in the (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.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.This report is being submitted late as it has been identified in remediation.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 01570, 0001825034 - 2018 - 01571, 0001825034 - 2018 - 01572, 0001825034 - 2018 - 01573 0001825034 - 2018 - 01574, 0001825034 - 2018 - 01575, 0001825034 - 2018 - 01576.

Event Description

It was reported that a patient underwent a right elbow arthroplasty.Subsequently, the patient experienced inability to open jar, inability to do heavy chores, inability to carry bag, inability to wash back, inability to cut, inability to do recreational activities, inability to perform social activities, moderate limitations in daily activites, moderate pain, and moderate difficulty sleeping.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr's were reported for this event.Please also see associated events: 0001825034 - 2018 - 04190; 0001825034 - 2018 - 04192; 0001825034 - 2018 - 04193; 0001825034 - 2018 - 04194; 0001825034 - 2018 - 04195; 0001825034 - 2018 - 01571; 0001825034 - 2018 - 01576; 0001825034 - 2018 - 01573; 0001825034 - 2018 - 01572; 0001825034 - 2018 - 01575.Unknown part/lot: baseplate, central screw, discovery ulna, peripheral screws, discovery humeral condyle kit, long intercalary segment, glenosphere, short intercalary segment, humeral tray, humeral bearing.211218 compr srs prox bdy - lg 42mm, lot unknown.211251 distal humeral body, srs, lot 706690 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.No medical records received.X-rays were submitted for review.Overall fit and alignment of the implants is grossly appropriate.No definite evidence for loosening or radiolucency.Of note, there is minimal bone seen along the humeral diaphysis which could be postsurgical or could represent evidence of osteolysis.This cannot be confirmed.Root cause was unable to be determined.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.

• Brand Name: COMPR SRS PROX BDY - LG 42MM
• Type of Device: ELBOW, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7302802
• MDR Text Key: 101157826
• Report Number: 0001825034-2018-01570
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: PK111746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• 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: 211218
• 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
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 92