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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 32MM; CERAMIC FEMORAL HEAD PROSTHESIS
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BIOMET UK LTD. CER BIOLOXD OPTION HD 32MM; CERAMIC FEMORAL HEAD PROSTHESIS Back to Search Results
Model Number N/A
Device Problems Activation, Positioning or Separation Problem (2906); Positioning Problem (3009)
Patient Problem Joint Dislocation (2374)
Event Date 01/15/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.Medical product: shell porous with multi holes 52 mm, catalog #: 00620205220, lot #: 63523301; medical product: liner 10 degree elevated rim 32 mm i.D.For use with 50/52/54 mm o.D.Shells, catalog #: 00631005032, lot #: 63996294; medical product: cer opt 12/14 tpr sleeve 0mm, catalog #: 650-1061, lot #: 2018051116; medical product: bone screw self-tapping 6.5 mm dia.15 mm length, catalog #: 00625006515, lot #: 62319085; medical product: bone screw self-tapping 6.5 mm dia.25 mm length, catalog #: 00625006525, lot #: 63610328; medical product: bone screw self-tapping 6.5 mm dia.30 mm length, catalog #: 00625006530, lot #: 64002719.Due to the fact that this is a legal claim, our legal department has been provided with the relevant facts from the customer.Zimmer gmbh (b)(6) legal department is well trained and passes all information concerning the case to our complaint and handling department.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
On (b)(6) 2017, the patient underwent a right hip replacement surgery at hospital (b)(6).On (b)(6) 2018, the patient underwent a first revision surgery at hospital (b)(6), due to implant fracture ((b)(4)).On (b)(6) 2019, the patient underwent a second revision surgery at hospital (b)(6), due to repositioning of the femoral head ((b)(4)).This complaint reports the second revision performed on (b)(6) 2019.This report is based on allegations set forth in patients notice and the allegations there in are unverified.
 
Event Description
On (b)(6) 2017, the patient underwent a right hip replacement surgery at (b)(6) (performed by dr.(b)(6).On (b)(6) 2018, the patient underwent a first revision surgery at (b)(6) (performed by dr.(b)(6), due to implant fracture (b)(4).On (b)(6) 2019, the patient underwent a second revision surgery at (b)(6) (performed by dr.(b)(6), due to repositioning of the femoral head (b)(4).This complaint reports the second revision performed on (b)(6) 2019.This report is based on allegations set forth in patients notice and the allegations there in are unverified.
 
Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, we have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found no similar complaints reported with these items.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.H3 other text: product not returned.
 
Manufacturer Narrative
This final / follow-up report is being submitted to relay additional information.G3: report source, foreign / event occurred in italy.As the product has not been received, the investigation was limited to the information provided; a review of radiographs, device history records and complaint history.Additional information received: one radiograph taken post revision surgery was reviewed by the scientific marketing associate director.The post revision radiograph shows that the positioning of the trabecular multi-holes shell is positioned too medially with a bony contact only at the equatorial rim of the shell.This positioning is the direct cause of the failure.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found no similar complaints reported with these items.The most likely root cause from the investigation findings is improper positioning of the liner and cup, the x-ray review does not suggest that the head contributed to the reported event.Risk assessment: previous risk assessment for this complaint is unchanged by the information provided by additional information.X-ray review suggests that the positioning of the liner and cup is considered the cause of revisions undertaken, and therefore no root cause is assignable related to item: 650-1056 ceramic head.Rmf documents have been reattached for reference, but outcome of the reported event is still considered in line with severity as anticipated for harm of dislocation for this event.No corrective or preventive actions are deemed necessary at this time.Due to fact that this is a legal claim, our legal department has been provided with the relevant facts from the customer.Further information concerning the case will be provided by the legal department to our complaint handling department as and when it becomes available.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.
 
Event Description
On (b)(6) 2017, the patient underwent a right hip replacement surgery at (b)(6) (performed by dr.(b)(6).On (b)(6) 2018, the patient underwent a first revision surgery at (b)(6) (performed by dr.(b)(6), due to implant fracture (b)(4).On (b)(6) 2019, the patient underwent a second revision surgery at (b)(6) (performed by dr.(b)(6), due to repositioning of the femoral head (b)(4).This complaint reports the second revision performed on (b)(6) 2019.This report is based on allegations set forth in patients notice and the allegations there in are unverified.
 
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Brand Name
CER BIOLOXD OPTION HD 32MM
Type of Device
CERAMIC FEMORAL HEAD PROSTHESIS
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key9864380
MDR Text Key190137273
Report Number3002806535-2020-00182
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
K082996
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 09/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number650-1056
Device Lot Number3408920
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/01/2020
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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