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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. GTS TRUNNION RASP SIZE 0; HIP INSTRUMENTS
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BIOMET FRANCE S.A.R.L. GTS TRUNNION RASP SIZE 0; HIP INSTRUMENTS Back to Search Results
Model Number N/A
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/20/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Concomitant medical products and therapy dates; acetabular liner 36mm f with part# 010000936 lot# 6548823, acetabular shell 54f with part# 010000664 lot# 6511558, acetabular liner 36mm f with part# 010000936 lot# 6558543, acetabular shell 54f with part# 010000664 lot# 6507580, gts standard femroral stem size +2 with part# ps129gp2 lot# j6419578, gts standard femroral stem size +1 with part# ps129gp1 lot# j6443623, delta modular ceramic head 036/0mm 12/14 m 12/14 with part# 650-0837 lot# 2019030226, delta modular ceramic head 036/0mm 12/14 with part# 650-0837 lot# 2019030757.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the rasp broke during surgery.The event happened during bilateral hip surgery (during femur's preparation).Since the rasp size 0 broke, the surgeon used another rasp with different size.No adverse patient consequences were reported.
 
Manufacturer Narrative
(b)(4).Concomitant medical products and therapy dates.Type of report: acetabular liner 36mm f with part# 010000936, lot# 6548823; acetabular shell 54f with part# 010000664, lot# 6511558; acetabular liner 36mm f with part# 010000936, lot# 6558543; acetabular shell 54f with part# 010000664, lot# 6507580; gts standard femroral stem size +2 with part# ps129gp2, lot# j6419578; gts standard femroral stem size +1 with part# ps129gp1, lot# j6443623; delta modular ceramic head 036/0mm 12/14 m 12/14 with part# 650-0837, lot# 2019030226; delta modular ceramic head 036/0mm 12/14 with part# 650-0837, lot# 2019030757.The product was returned and lab analysis was performed.The returned device has been inspected according to an internal checklist, as part of our documentation process, which describes the different items to review.The product analysis shows that the product were received in two parts.We noticed that the product was broken at the top of the piece.The reported event could be confirmed.The review of the device manufacturing quality record indicates that 25 products gts trunnion rasp s-0, reference 110025198, lot number 427070 were manufactured on 3 october 2017.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the event described in the complaint.No other similar complaints have been recorded for gts trunnion rasp s-0, reference 110025198, lot 427070 on the reported event within one year.According to available data, the exact root cause is traced to device design (design / raw material combination was leading to a weak in the trunnion connexion).Corrective action has been initiated to address reported issue.A recall was performed on the affected devices.Please note that the devices in the scope of this recall were not delivered to the usa.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 was reported that the rasp broke during surgery.The event happened during bilateral hip surgery (during femur's preparation).Since the rasp size 0 broke, the surgeon used another rasp with different size.No adverse events have been reported as a result of the malfunction.
 
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Brand Name
GTS TRUNNION RASP SIZE 0
Type of Device
HIP INSTRUMENTS
Manufacturer (Section D)
BIOMET FRANCE S.A.R.L.
plateau de lautagne bp75
valence cedex 26903
FR  26903
MDR Report Key8762058
MDR Text Key159518427
Report Number3006946279-2019-00306
Device Sequence Number1
Product Code HTR
UDI-Device Identifier0880304829909
UDI-Public(01)0880304829909
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
Remedial Action Recall
Type of Report Initial,Followup
Report Date 12/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number110025198
Device Lot Number427070
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2019
Was the Report Sent to FDA? No
Date Manufacturer Received11/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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