MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 5.0 MM DIA CORTICAL SCREW-RED FIXED ANGLE 3.5 MM HEX HEAD; ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, STERILE

Model Number N/A

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs: 47248402250 5.0 mm dia cortical screw-red fixed angle 3.5 mm hex head lot# unk mdr: 0001822565-2022-00777.47248402250 5.0 mm dia cortical screw-red fixed angle 3.5 mm hex head lot# unk mdr: 0001822565-2022-00778.47248403050 5.0 mm dia cortical screw - red fixed angle 3.5 mm hex head lot# unk mdr: 0001822565-2022-00780.47248403550 5.0 mm diameter cortical screw-red fixed angle 3.5 mm hex head lot# unk mdr: 0001822565-2022-00781.47249530009 tibial nail-yellow 9.3 mm dia 30 cm length lot# unk mdr: 0001822565-2022-00782.00114704041 4.0mm cann scr 1/2thr 40mm lg lot# unk.Mdr: alliance partner provided devices.Zimmerbiomet does not have reporting responsibility.00114704041 4.0mm cann scr 1/2thr 40mm lg lot# unk.Mdr: alliance partner provided devices.Zimmerbiomet does not have reporting responsibility.

Event Description

It was reported the patient underwent a knee procedure in.Subsequently, approximately 2 years post procedure the patient has been experiencing pain with concerns of an allergic reaction.Patient also states she does not feel the bone has ever healed.Original surgery was needed due to a broken leg at which time a rod was implanted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated:.

Event Description

It was reported open reduction and internal fixation right lower leg.Subsequently, 2 years, 10 months post procedure, the patient reported about experiencing pain, concerns of an allergic reaction, and states she does not feel the bone has ever healed.No recent medical records provided.Original surgery was needed due to a broken leg at which time a rod was implanted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided.The reported products were reviewed for compatibility with no issues noted.Review of complaint history identified no additional similar complaints for the reported item(s).Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: initial appointments showed healing as expected and implants fixated properly with ankle in good position.At subsequent office visits, patient reported ankle pain, dex scan showed low mineral density.At office visit one month later patient was full weight bearing with cam boot using single crutch occasionally, incisions healing without concern for infection, ankle 1+ swelling, x-ray: healing and alignment of tibia and ankle, no hardware failure.Still working with pt, uses cane for stability, x-ray: tibia shaft healed 3 of 4 cortices, hardware in good position, fibula shaft unchanged with healing.Ankle, healed posterior malleolus fracture post screw fixation.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: three views of the right tibia and fibula demonstrate an intramedullary rod within the tibial with three proximal and three distal interlocking screws.Single screw also seen with the distal tibia.No fracture.No radiopaque foreign body.Healed fracture of the mid tibial diaphysis and distal fibular diaphysis.Overall fit and alignment of the implants is appropriate.Normal bone quality.No evidence for reaction.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this 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.

Event Description

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

• Brand Name: 5.0 MM DIA CORTICAL SCREW-RED FIXED ANGLE 3.5 MM HEX HEAD
• Type of Device: ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, STERILE
• 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 13841369
• MDR Text Key: 289512639
• Report Number: 0001822565-2022-00779
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082770
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 47248402750
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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 Sex: Female
• Patient Race: White