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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH UNKNOWN ZIMMER HEAD; HIP PROSTHESIS

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ZIMMER SWITZERLAND MANUFACTURING GMBH UNKNOWN ZIMMER HEAD; HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Hematoma (1884); Unequal Limb Length (4534)
Event Date 01/10/1996
Event Type  Injury  
Manufacturer Narrative
(b)(4).D10 ¿ unknown ms-30 stem; item# unknown; lot# unknown.Unknown sl shell; item# unknown; lot# unknown.#1 unknown screw; item# unknown; lot# unknown.#2 unknown screw; item# unknown; lot# unknown.#3 unknown screw; item# unknown; lot# unknown.Unknown cement; item# unknown; lot# unknown.G2 ¿ foreign ¿ switzerland.H10 ¿ h3 ¿ other: device evaluation could not be performed as part# and lot# unknown.Also, device location is unknown.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
 
Event Description
It was reported that an initial left total hip arthroplasty was performed approximately twenty-seven and a half years ago.Subsequently, the patient had considerable excess leg length on the operative side and required revision.The patient underwent a revision of the femoral head with hematoma evacuation and lysis of adhesions thirty-five days after the initial surgery.Due diligence is in progress for this complaint; to date no additional information or product has been received.
 
Manufacturer Narrative
(b)(4).H10: h3: other: device evaluation could not be performed as part# and lot# unknown.Also, device location is unknown.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.Review of manufacturing records cannot be performed without product identification.Device is used for treatment.Medical documents in the form of surgical reports were provided which detail the reported event.Based on the available information, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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.
 
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Brand Name
UNKNOWN ZIMMER HEAD
Type of Device
HIP 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 Key17162277
MDR Text Key317587253
Report Number0009613350-2023-00323
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
Reporter Country CodeSZ
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,Followup
Report Date 07/19/2023
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 Lay User/Patient
Device Model NumberN/A
Device Catalogue NumberUNKNOWN ZIMMER HEAD
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/25/2023
Initial Date FDA Received06/20/2023
Supplement Dates Manufacturer Received07/17/2023
Supplement Dates FDA Received07/19/2023
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
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEE H10 NARRATIVE.
Patient Outcome(s) Hospitalization; Required Intervention;
Patient SexMale
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