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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM SM PMA; KNEE PROTHESIS

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BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM SM PMA; KNEE PROTHESIS Back to Search Results
Model Number N/A
Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Joint Dislocation (2374); Tissue Breakdown (2681)
Event Date 06/12/2023
Event Type  Injury  
Event Description
It was reported that the patient underwent an initial partial knee arthroplasty.Approximately 7 years later the patient was revised to a total knee arthroplasty.During the revision, medial laxity was noted, significant damage to the medial capsular tissue and portions of the mcl, as well as bone quality to be soft and tissue looked to be atrophied.Due diligence is in progress for this complaint; to date no additional information or product has been received.
 
Manufacturer Narrative
(b)(4).D10 ¿ oxf uni tib tray sz c lm pma item#154722 lot#unknown.Oxf anat brg lt sm size 7 pma item#159544 lot#865430.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00221, 3002806535-2023-00223.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.No products were returned or pictures provided; visual and dimensional evaluations could not be performed.Devices are used for treatment.Medical records were provided and reviewed by a health care professional, pre op x-ray and ct showed polyethylene bearing dislocation.Under anesthesia exam noted increased valgus laxity with and endpoint.Valgus laxity was noted in extension and 20 degrees flexion, some degree of mcl injury noted and improved stability noted with size 7 insert.With the available information, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name
OXF TWIN-PEG CMNTD FEM SM PMA
Type of Device
KNEE PROTHESIS
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
Manufacturer (Section G)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK   CF31 3XA
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key17276819
MDR Text Key318551971
Report Number3002806535-2023-00222
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/22/2023
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? Yes
Device Operator Lay User/Patient
Device Model NumberN/A
Device Catalogue Number161468
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/20/2023
Initial Date FDA Received07/07/2023
Supplement Dates Manufacturer Received08/18/2023
Supplement Dates FDA Received08/22/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient SexFemale
Patient Weight70 KG
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