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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL HEAD 28MM "S" 12/14; HIP PROSTHESIS

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ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL HEAD 28MM "S" 12/14; HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problems Biocompatibility (2886); Insufficient Information (3190)
Patient Problems Metal Related Pathology (4530); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/15/2021
Event Type  Injury  
Manufacturer Narrative
This product is manufactured by zimmer biomet winterthur and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet winterthur manufactures a similar device that is cleared or distributed in the united states.Medical products: metasul, alpha insert, gg/28; catalog#: 01.00010.407; lot#: 2220524; fitmore, shell with screw cones, uncemented, 48/gg; catalog#: 01.00024.548; lot#: 2213918; vite spon.Tit.Diam.6,5x30; catalog#: 02.06000.030; lot#: 040104d; vite spon.Tit.Diam.6,5x25, gg/28; catalog#: 02.06000.025; lot#: 040111c.Therapy date: (b)(6) 2021.The manufacturer received other source document 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 an unknown side and underwent a revision surgery due to metallosis.
 
Event Description
Investigation has been completed.
 
Manufacturer Narrative
Investigation results were made available.Event description: it was reported that the products were implanted on (b)(6) 2004 and revised on (b)(6) 2021 due to metallosis.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Patient data: a.G., 73 years of age.No medical data relevant to the case has been received.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the compatibility check was performed and showed that the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that the products were implanted on (b)(6) 2004 and revised on (b)(6) 2021 due to metallosis.The devices were not returned; therefore, a device examination could not be performed.In addition, no medical records have been received; therefore, the reported event could not be confirmed.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Due to the significant lack of information, an investigation could not be conducted; therefore, the reported event could not be confirmed.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2021-00075-1.
 
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Brand Name
METASUL HEAD 28MM "S" 12/14
Type of Device
HIP PROSTHESIS
Manufacturer (Section D)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ  8404
MDR Report Key11337386
MDR Text Key232340223
Report Number0009613350-2021-00072
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 08/11/2021
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? Yes
Device Operator Lay User/Patient
Device Expiration Date02/15/2009
Device Model NumberN/A
Device Catalogue Number19.28.05
Device Lot Number2207154
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/01/2021
Initial Date FDA Received02/17/2021
Supplement Dates Manufacturer Received07/14/2021
Supplement Dates FDA Received08/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age73 YR
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