MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE SRS IC SEG - 30MM; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Tingling (2171)

Event Date 04/15/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event.Please see associated reports: 0001825034 - 2018 - 01410, 0001825034 - 2018 - 01411, 0001825034 - 2018 - 01412, 0001825034 - 2018 - 01413, 0001825034 - 2018 - 01414.Concomitant medical products: 211224 compr srs ic seg - 30mm, unknown lot, 211237 compr srs mod stem - 10x100mm, unknown lot, 211253 compr srs 50mm dst hml bdy rt, unknown lot, unknown part/lot; proximal body, regenerx augment, pps augment, seas augment.Report source: foreign.The event occurred in the (b)(6).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 that the patient found it severely difficult to open jar, do heavy chores, carry bag, wash back, cut grass, perform social activities, and perform daily activities.The patient experienced moderate pain and moderate tingling.Attempts have been made and no further information has been made available at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.211237, compr srs mod stem - 10x100mm, 119270.211253, compr srs 50mm dst hml bdy rt, 494170.Unknown, unknown discovery ulna, unknown.Unknown, unknown discovery humeral condyle kit, unknown.Reported event was unable to be confirmed due to limited information received from the customer.The product was not returned for the investigation, therefore a visual and dimensional evaluations could not be performed.X-rays were submitted to mmi for review.Evaluation is limited but overall thickened alignment of the implants appears to be appropriate.Bone quality suggests osteopenia.Dhr was reviewed and no discrepancies were found.Root cause could not be determined with information available.Contributing factors to the pain could be the osteoporosis and rheumatoid arthritis.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: COMPREHENSIVE SRS IC SEG - 30MM
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7306140
• MDR Text Key: 101267191
• Report Number: 0001825034-2018-01409
• Device Sequence Number: 1
• Product Code: JDC
• 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
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 211224
• Device Lot Number: 067950
• Other Device ID Number: (01) 00880304507784
• 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): Other
• Patient Age: 74 YR
• Patient Weight: 78