MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN COMPREHENSIVE SRS FLANGE; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 11/03/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event.Please see associated reports: 0001825034 - 2018 - 01205.Concomitant products: unknown, proximal body, unknown.Unknown, regenerex augment, unknown.Unknown, pps augement, unknown.Unknown, seas augement, unknown.The 211266 compr srs anti rot ic seg-30mm, lot unknown.The 211236 compr srs mod stem, lot unknown.The 211251 compr srs 60mm dst hml bdy lt, lot unknown.Report source, foreign - the event occurred in (b)(4).Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.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 was not provided.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.Device remains implanted.

Event Description

It was reported by clinical study 540 that a patient underwent left elbow arthroplasty.Subsequently, post-operative pain and the following experiences were reported at the follow up visits via the quickdash questionnaire: six (6) month - severely difficult to open jar, severely difficut to do heavy chores, moderately difficult to carry bag, moderately difficult to wash back, moderately difficult to cut, unable to do recreational activities, moderately limited with daily activities; one (1) year - unable to open jar, moderately difficult to do heavy chores, moderately difficult to carry bag, moderately difficult to wash back, severely difficult to do recreational activities; three (3) year - unable to open jar, unable to do heavy chores, unable to wash back, moderately difficult to cut, unable to do recreational activities and moderately limited in daily activities.No additional information available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.211266, compr srs anti rot ic seg-30mm, 118810.Unknown, unknown discovery humeral condyle kit, unknown.211236, compr srs mod stem - 8x100mm, 027570.211251, compr srs 60mm dst hml bdy lt, 457210.Unknown, unknown discovery ulna, unknown.

• Brand Name: UNKNOWN COMPREHENSIVE SRS FLANGE
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7285069
• MDR Text Key: 100528764
• Report Number: 0001825034-2018-01204
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• 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
• Date Manufacturer Received: 05/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 62 YR
• Patient Weight: 48