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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 28MM; HIP PROSTHESIS
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BIOMET UK LTD. CER BIOLOXD OPTION HD 28MM; HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Pain (1994)
Event Date 08/30/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: medical product: epoly rlc 10 deg 28mm sz22, catalog #: ep-105812, lot #: 368460; medical product: rnglc locking ring sz 22, catalog #: 105422, lot #: 021130; medical product: unk cup, catalog #: not reported, lot #: not reported; medical product: unk stem, catalog #: not reported, lot #: not reported.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
 
Event Description
It was reported by legal counsel that a patient underwent a left hip arthroplasty.Subsequently, the patient was revised due to pan.During the procedure, inspection of the joint space showed that there were multiple fragments of polyethylene, that the prosthetic femoral head was articulating with the acetabular shell, and that there was striping over the weight bearing portion.All products were revised.This report is based on allegations set forth in patients notice and the allegations there in are unverified.
 
Event Description
It was reported by legal counsel that a patient underwent a left hip arthroplasty.Subsequently, the patient was revised due to pain and wear.During the procedure, inspection of the joint space showed that there were multiple fragments of polyethylene, that the prosthetic femoral head was articulating with the acetabular shell, and that there was striping over the weight bearing portion.All products were revised.This report is based on allegations set forth in patients notice and the allegations there in are unverified.
 
Manufacturer Narrative
(b)(4).This report is to relay additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.Without the opportunity to examine the complaint product, the root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Unique identifier (udi) number: (b)(4).The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
 
Event Description
It was reported by legal counsel that a patient underwent a left hip arthroplasty.Subsequently, the patient was revised due to pain and wear.During the procedure, inspection of the joint space showed that there were multiple fragments of polyethylene, that the prosthetic femoral head was articulating with the acetabular shell, and that there was striping over the weight bearing portion.All products were revised.This report is based on allegations set forth in patients notice and the allegations there in are unverified.
 
Manufacturer Narrative
(b)(4).This final follow-up report is being submitted to relay additional information.We have been provided with the patients date of birth (on (b)(6) 1946).If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.H3 other text: item not returned to manufacturer.
 
Event Description
Left hip revision due to pain and wear.It was reported by legal counsel that a patient underwent a left hip arthroplasty.Subsequently, the patient was revised due to pain and wear.During the procedure, inspection of the joint space showed that there were multiple fragments of polyethylene, that the prosthetic femoral head was articulating with the acetabular shell, and that there was striping over the weight bearing portion.All products were revised.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 28MM
Type of Device
HIP PROSTHESIS
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key9103693
MDR Text Key159592001
Report Number3002806535-2019-00761
Device Sequence Number1
Product Code LZO
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,health
Type of Report Initial,Followup,Followup,Followup
Report Date 04/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number650-1055
Device Lot Number428080
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEE H10.
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age71 YR
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