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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DEPTH GAUGE HIP INSTRUMENT

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ZIMMER SWITZERLAND MANUFACTURING GMBH DEPTH GAUGE HIP INSTRUMENT Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Insufficient Information (4580)
Event Date 08/02/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 12. 5 standard offset reduced neck length; catalog#: 00-7711-012-10; lot#: 64632166 bone screw self-tapping 6. 5 mm dia. 20 mm length; catalog#: 00-6250-065-20; lot#: 64690841 biolox delta, ceramic femoral head, s, 32/-3. 5, taper 12/14; catalog#: 00-8775-032-01; lot#: 3005283 shell with cluster holes porous 48 mm o. D. Size gg for use with gg liners; catalog#: 00-8753-048-01; lot#: 64527624 bone screw self-tapping 6. 5 mm dia. 20 mm length; catalog#: 00-6250-065-20; lot#: 64690841 biolox delta ceramic taper liner, size gg / 32 i. D. For use with 48 mm o. D. Size gg shell; catalog#: 00-8775-008-32; lot#: 3041407. Therapy date: unknown. The manufacturer received x-ray and other source documents for review. The manufacturer did not receive the device for investigation. As no lot number was provided, the device history records could not be reviewed. A cause for this specific event cannot be ascertained from the information provided. As soon as supplemental information becomes available an updated report will be submitted. Zimmer biomet¿s reference number of this file is (b)(4).
 
Event Description
During a surgery while implanting the acetabular cup, a large resistance was encountered while inserting the screw. The screw channel was checked and it was reported that the head end of the depth gauge was missing. Intra-operative x-ray fluoroscopy was conducted and the fractured tip was found inside the patient. Immediate attempt was made to remove the fractured tip. The surgeon had to expand the scope and an additional opening had to be done due to the deep positioning of the fractured tip. Complete anastomosis of the fractured tip was confirmed on the operating table. The surgery was completed after removing the fractured tip. There was a surgical delay of 2 hours. Note: the implantation and explantation dates are left empty as the device involved in this complaint is an instrument. Hence, no expiration date is captured, for the same reason.
 
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Brand NameDEPTH GAUGE
Type of DeviceHIP INSTRUMENT
Manufacturer (Section D)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer (Section G)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key12353504
MDR Text Key267823015
Report Number0009613350-2021-00421
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 08/23/2021 Patient Sequence Number: 1
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