MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OFFSET END CAP 11X10MM; SCREW, FIXATION

Catalog Number 14-441282

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 04/07/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Fibula comp lock plate 8h ste cat: 856204008 lot: 489020.Tibial nail 12.0mm x 300mm cat: 40930 lot: 286300.3.5x14mm low pro cort scr ste cat: 851235014 lot: 199400.3.5x14mm low pro cort scr ste cat: 851235014 lot: 979670.3.5x10mm cort lock scr ste cat: 856135010 lot: 485430.3.5x12mm cort lock scr ste cat: 856135012 lot: 486790.3.5x12mm cort lock scr ste cat: 856135012 lot: 486960.3.5x14mm cort lock scr ste cat: 856135014 lot: 716290.Ti-dble lead cort 5.0x32mm scr cat: 14-405032 lot: 497210.Ti-dble lead cort 5.0x34mm scr cat: 14-405034 lot: 656950.Ti-dble lead cort 5.0x36mm scr cat: 14-405036 lot: 220160.Ti-dble lead cort 5.0x38mm scr cat: 14-405038 lot: 682280.Ti-dble lead cort 5.0x42mm scr cat: 14-405042 lot: 483550.Foreign: (b)(6).It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.

Event Description

It was reported that the patient had an allergic reaction to the implants.It was indicated that the patient will be revised.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Device history record 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.

Event Description

No further event information available at the time of this report.

• Brand Name: OFFSET END CAP 11X10MM
• Type of Device: SCREW, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11772297
• MDR Text Key: 250668322
• Report Number: 0001825034-2021-01372
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 14-441282
• Device Lot Number: 625640
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 70