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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL LDH, HEAD ADAPTER, M, 0, TAPER 12/14-18/20 HIP PROSTHESIS

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ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL LDH, HEAD ADAPTER, M, 0, TAPER 12/14-18/20 HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Cyst(s) (1800); Bone Fracture(s) (1870); Muscle Weakness (1967); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)
Event Date 04/18/2018
Event Type  Injury  
Manufacturer Narrative
Medical products: femoral stem press-fit collarless 12/14 neck taper standard body standard neck offset size 13 138mm. Stem length cementless; catalog#: 00-7864-013-00; lot#: 61256425. Therapy date: (b)(6) 2018. The manufacturer received other source documents for review. The manufacturer did not receive the device for investigation. Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming. 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
Patient was implanted on the right side and underwent revision due to multiple complications which were as follows: aseptic lymphocyte-dominant vasculitis- associated lesion (alval). Pelvic ring fracture (patient bone fracture). Hip muscle weakness and muscle destruction related to alval. Cobalt and chromium ion reaction - type 4. Large pseudocyst with approximately a liter of fluid that was slightly green-tinged consistent with alval. Extensive trunnionosis with a blackened trunnion. Fibrous component on the acetabular component and along the pelvis ring fracture. There was approximately 2000ml blood loss during revision surgery. The patient was given 2 units of packed red blood cells and 2 units of ffp.
 
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Brand NameMETASUL LDH, HEAD ADAPTER, M, 0, TAPER 12/14-18/20
Type of DeviceHIP PROSTHESIS
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 Key11874791
MDR Text Key252628237
Report Number0009613350-2021-00234
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K053536
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2014
Device Model NumberN/A
Device Catalogue Number01.00185.146
Device Lot Number2516387
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/29/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/12/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 05/25/2021 Patient Sequence Number: 1
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