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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. UNKNOWN SCREW; SCREW, FIXATION Back to Search Results
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  
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, 0001822565-2023-01139, 0001822565-2023-01140, 0001822565-2023-01141, 0001822565-2023-01142, 0001822565-2023-01143, 0001822565-2023-01144, 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 30-jul-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.
 
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.
 
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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 Key16817470
MDR Text Key314035324
Report Number0001822565-2023-01138
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
N/A
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/14/2023
Initial Date FDA Received04/26/2023
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 Number1
Patient Outcome(s) Other;
Patient Age91 YR
Patient SexFemale
Patient Weight86 KG
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