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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT; PROSTHESIS, HIP
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ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Cyst(s) (1800); Tissue Damage (2104); Reaction (2414)
Event Date 12/09/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: zimmer 00620205822, lot 60986062 tm shell 58mm.Zimmer 00786401420, lot 61384808 tm stem 14.Zimmer 00630505840, lot 61157862 longevity liner 40mm, 3.5mm offset.The device will not be returned for analysis, as the device location is unknown; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-01630.0001822565-2020-01631.
 
Event Description
It was reported the patient underwent an initial left total hip arthroplasty performed 10 years ago.Subsequently, the patient was revised less than one year ago due to metallosis and trunnion failure.During the revision, a large cyst was debrided from the joint and osteolysis was noted around the proximal femoral component.All components were removed with difficulty but replaced without further complications.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
This is a duplicate of (b)(4).These events have the same surgeons (initial and revision), hospitals, product id, event dates, pt name, and event detail.All medical record and legal info have been transferred over to (b)(4).
 
Event Description
This is a duplicate of (b)(4).These events have the same surgeons (initial and revision), hospitals, product id, event dates, pt name, and event detail.All medical record and legal info have been transferred over to (b)(4).
 
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Brand Name
FEMORAL HEAD STERILE PRODUCT
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
MDR Report Key10060601
MDR Text Key191097570
Report Number0002648920-2020-00250
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
K953337
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 08/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/19/2018
Device Model NumberN/A
Device Catalogue Number00801804003
Device Lot Number61123356
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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