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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, L¸ 40/+3.5, TAPER 12/14
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ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, L¸ 40/+3.5, TAPER 12/14 Back to Search Results
Model Number N/A
Device Problem No Apparent Adverse Event (3189)
Patient Problem Hip Fracture (2349)
Event Date 05/02/2016
Event Type  Injury  
Manufacturer Narrative
The manufacturer did not receive the devices for investigation.X rays, operative reports, pns and medical records were provided.Where lot numbers were received for the device, the device history record were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available, that changes this assessment, an amended medical report will be submitted.Two other complaints were open for the same patient.First revision: cmp-0229009 (durom revised).Third revision: cmp-0231483 (revision of biolox option head).(b)(4).
 
Event Description
It was reported that the patient was implanted a biolox delta, ceramic femoral head, l¸ 40/+3.5, taper 12/14 on the right side on (b)(6) 2016.The patient was revised on (b)(6) 2016 due to revised due to periprosthetic fracture (stem and head revised).
 
Manufacturer Narrative
Trend analysis: no trend identified.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.It is reported that the patient underwent revision surgery due to the periprosthetic fracture after 5 days in vivo time and the ceramic head was revised along with the stem.However, it is realized in the surgical report that only the ceramic head was revised.The femoral stem was left in.No x-rays were received for the investigation which were taken in the time interval of the product stayed implanted.Implantation surgery dated (b)(6) 2016.Failed right total right arthroplasty due to acetabular component loosening.Findings: synovial hypertrophy and particulate dark stained fluid was noted with the hip joint.Severe corrosive changes were identified at the head adaptor/neck junction.Stem was observed to be well positioned, however it was noted that the neck module had cold welded to the stem module.Therefore, it was decided to remove the stem together with the head.Acetabular component was observed to be well positioned, however, no evidence of bony ingrowth.No damage to host bone about the acetabulum.Acetabuluar component replaced by biomet osteotite cup.Wagner sl stem was implanted along with the head.Stability was excellent.No other abnormalities were observed.Revision surgery report dated (b)(6), 2016.Periprosthetic fracture, right thr.Displaced fracture, right greater trochanter.Findings: a displaced greater trochanter fracture was identified.Components were noted to be well positioned.40mm x +3.5mm biolox delta head was replaced by 40mm x 0mm biolox delta head.No chronic infection identified.The greater trochanter fracture fixated by grip with two cables.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.The compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Root cause determination using dfmea (b)(4): fracture of bone, implant due to too much press fit possible: correct use of the device is not under zimmer biomet control.It is likely that the operational procedure failure might have led to fracture of the bone.However it is also possible that the patient did not follow the healing plan that she had to.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer's reference number of this file is (b)(4).
 
Event Description
It was reported that the patient was implanted a biolox delta, ceramic femoral head, l¸ 40/+3.5, taper 12/14 on the right side on (b)(6) 2016.The patient was revised on (b)(6) 2016 due to periprosthetic fracture (only head was revised).
 
Manufacturer Narrative
The case was reopened as additional information was received and is included in this report.Zimmer biomet¿s reference number of this file is (b)(4).
 
Event Description
It was now reported that the patient is pursuing a legal claim.
 
Manufacturer Narrative
Surgical reports were received and have been reviewed: implantation surgery dated (b)(6) 2016: preoperative diagnosis: failed right total right arthroplasty due to acetabular component loosening findings: synovial hypertrophy and particulate dark stained fluid was noted with the hip joint.Severe corrosive changes were identified at the head adaptor/neck junction.Stem was observed to be well positioned, however it was noted that the neck module had cold welded to the stem module.Therefore, it was decided to remove the stem together with the head.Acetabular component was observed to be well positioned, however, no evidence of bony ingrowth no damage to host bone about the acetabulum.Acetabular component replaced by biomet osteotite cup.Wagner sl stem was implanted along with the head.Stability was excellent.No other abnormalities were observed.Revision surgery report dated (b)(6) 2016: preoperative diagnosis: periprosthetic fracture, right thr.Displaced fracture, right greater trochanter findings: a displaced greater trochanter fracture was identified.Components were noted to be well positioned.40mm x +3.5mm biolox delta head was replaced by 40mm x 0mm biolox delta head with titanium sleeve.No chronic infection identified.Leg lengths were equal.The greater trochanter fracture fixated by stryker grip with two cables.The hip was ranged through full range motion and the fragments appeared stable.Conclusion summary it is likely that the operational procedure failure might have led to fracture of the bone.However it is also possible that the patient did not follow the healing plan that she had to.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed again.Zimmer¿s reference number of this file is (b)(4).
 
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Brand Name
BIOLOX DELTA, CERAMIC FEMORAL HEAD, L¸ 40/+3.5, TAPER 12/14
Type of Device
BIOLOX DELTA, CERAMIC FEMORAL HEAD
Manufacturer (Section D)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ  8404
MDR Report Key5769022
MDR Text Key48745360
Report Number0009613350-2016-01031
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
PMA/PMN Number
PK071535
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup,Followup
Report Date 01/23/2018
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? No
Device Operator Lay User/Patient
Device Model NumberN/A
Device Catalogue Number00-8775-040-03
Device Lot Number2832511
Other Device ID Number00889024430419
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/09/2016
Initial Date FDA Received07/05/2016
Supplement Dates Manufacturer ReceivedNot provided
12/11/2017
01/17/2018
Supplement Dates FDA Received10/13/2016
01/05/2018
01/23/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age63 YR
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