MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN SCREW; SCREW, FIXATION

Model Number N/A

Device Problems Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Pain (1994); Non-union Bone Fracture (2369)

Event Date 11/01/2017

Event Type  Injury  

Event Description

It was reported that the patient underwent an elbow surgery.Subsequently, the patient presented with a non-union at the last consultation visit which led to the decision that the device will be removed.The patient is awaiting an additional surgery.In the meantime patients suffers from chronic elbow pain which is being treated with analgesics.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4) multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00138, 0001822565-2023-01133, 0001822565-2023-01134, 0001822565-2023-01135, 0001822565-2023-01136, 0001822565-2023-01137, 0001822565-2023-01138, 0001822565-2023-01139, 0001822565-2023-01140, 0001822565-2023-01141, 0001822565-2023-01142, 0001822565-2023-01143, 0001822565-2023-01145, and 0001822565-2023-01146.D10: distal medial humeral plate left 5 holes 104 mm length cat: 47235800805 lot: unk.Unknown plate.Unknown screws qty 12.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: (b)(6) 2017: xray shows fixation intact- sign of bone healing.(b)(6) 2017: metalwork is completely loose and there are signs that the fracture itself has now healed.Will rule out infection prior to removal of hardware.(b)(6) 2017: there is miserable discomfort in her arm with all movement of the elbow.There are no signs of infection.Ct ordered for signs of progression towards union.(b)(6) 2018: multiple cancellations of surgery dates due to non-patient related events.Currently planned date of surgery is (b)(6) 2018.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: extensive screw loosening of both the original humeral orif and subsequent revision with fracture non-union and malalignment as described.Initial bone quality was mildly osteopenic with marked progression over time to severe osteopenia.The oblique nature of the original fracture and the osteopenia could contribute to the hardware failure and non-union of the bone fracture 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.H3 other text : product remains implanted.

• Brand Name: UNKNOWN SCREW
• Type of Device: SCREW, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16817520
• MDR Text Key: 314033293
• Report Number: 0001822565-2023-01144
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 91 YR
• Patient Sex: Female
• Patient Weight: 86 KG