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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. TPRLC COCR 10X140MM 12/14; UNCOATED FEMORAL STEM PROSTHESIS, ONE-PIECE
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BIOMET UK LTD. TPRLC COCR 10X140MM 12/14; UNCOATED FEMORAL STEM PROSTHESIS, ONE-PIECE Back to Search Results
Model Number N/A
Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)
Patient Problems Death (1802); No Information (3190)
Event Date 01/18/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Unique identifier (udi) number: (b)(4).Concomitant medical products: medical product: bi-polar 28 cup 55mm, item no: 165234, lot no: 6170954; medical product: delta cer fm hd 028/0mm 12/14, item no: 650-0831, lot no: 2018032021; medical product: refobacin bone cement r 1x40-3, item no: 3003940001-3, lot no: 815aak0709; medical product: optivac m, item no: 4160, lot no: 0001316296.Report source, foreign - event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It has been reported by the hospital that a patient underwent an initial hip replacement surgery.Subsequently, a revision procedure was performed due to femoral stem loosening.
 
Event Description
It has been reported that a patient underwent an initial hip replacement surgery.Initially, it was reported that a revision procedure was performed due to femoral stem loosening.However, after reviewing the linked complaint (b)(4), it was found that the patient was not revised due to loosening, but was revised due to sepsis.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a3, a4, b4, b5, d2, d4, d10, g4, g7, h1, h2, h3, h6, h10.D4 unique identifier (udi) number: (b)(4).G3: report source, foreign - event occurred in poland.Implant did not contribute to the patient¿s condition.Revision due to sepsis.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
It has been reported that a patient underwent an initial hip replacement surgery.Initially, it was reported that a revision procedure was performed due to femoral stem loosening.However, after reviewing the linked complaint (b)(4), it was found that the patient was not revised due to loosening, but was revised due to sepsis.
 
Manufacturer Narrative
G3: report source, foreign - event occurred in poland.E1: postal code: (b)(6).Products have been returned to biomet uk ltd for evaluation and forwarded to a research engineer for investigation.Summary of investigation: a taperloc cocr stem with a j-hook stem extractor still attached was received for examination.The stem was revised after 2 months and 24 days.As described in the complaint description, loosening was initially suspected as the reason for revision.However, after receiving further information from the surgeon it was established that the patient was admitted to the hospital due to sepsis.The surgeon decided to remove the implant in an attempt to cure the sepsis.Moreover, the complaint description states that when the patient was revised there was absolutely no indication that the implant could in any way contribute to the state of the patient (there was no signs of infection, loosening or other problems around the implant).The implant was removed and replaced with spacer (even though there was no evidence that the implant had any negative effect).Visual examination of the stem indicates an overall good condition.Minor damages observed on the component were likely caused by the extraction procedure and the contact of the stem with the j-hook extractor.Surgical reports and radiographs from the primary and revision surgery have not been provided for review.Additionally, patient information such as age, height, and weight have not been provided due to country regulations.Review of the device mhrs confirmed that the stem had been manufactured and sterilised correctly.No evidence was found that the taperloc stem malfunctioned during use or that it could have caused the reported sepsis in this patient.Conclusion: a taperloc cocr cemented stem was revised after 2 months and 24 days.The analysis of the returned stem with a j-hook extractor did not find any evidence that the taperloc stem malfunctioned during use or that it could have caused the reported sepsis.Risk assessment: from the information provided, root cause cannot be confirmed and the complaint indicates that harm was not related to the device, therefore, a risk assessment cannot be performed based on the information provided.Corrective and preventive actions taken: no actions needed at this time.This complaint was determined not to be a new confirmed quality or manufacturing issue.Complaints are monitored through monthly complaint review (reference (b)(4)) in order to identify potential adverse trends.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
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Brand Name
TPRLC COCR 10X140MM 12/14
Type of Device
UNCOATED FEMORAL STEM PROSTHESIS, ONE-PIECE
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key8331123
MDR Text Key135874661
Report Number3002806535-2019-00110
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 06/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number650-0338
Device Lot Number6395452
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2019
Was the Report Sent to FDA? No
Date Manufacturer Received06/04/2020
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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