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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 PROSTHESIS

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BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM SM PMA; KNEE PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Loss of Range of Motion (2032)
Event Date 08/31/2022
Event Type  Injury  
Event Description
It was reported a patient had a right unicompartmental knee arthroplasty.Subsequently, approximately three (3) months post op underwent a manipulation under anesthesia due to stiffness and limited range of motion.No further information or outcome was provided.Attempts have been made and all additional information received has been included in this report.
 
Manufacturer Narrative
(b)(4).D10: vanguard m uni brng b5 rm/ll; ref# (b)(4); lot#632210.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.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Arthrofibrosis is defined as the development of fibrous scar tissue within or surrounding a joint.Arthrofibrosis is a known postoperative procedure-related complication that can occur from surgical implantation of new joint replacement as well as from previous injuries or surgical procedures.Scar tissue formation is a normal healing response; however, the buildup of such can result in pain, stiffness, limited range of motion, and difficulty properly ambulating.If excess scar tissue develops, conservative measures such as exercises or physical therapy would be attempted first.If these attempts fail, surgical intervention such as manipulation under anesthesia, arthroscopic arthrolysis, or open arthrotomy would become necessary to remove the fibrous tissue and restore joint function.The device history records were not reviewed as the reported event was procedure-related.The root cause of the reported event is determined to be unrelated to the implanted zimmer biomet device.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.
 
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Brand Name
OXF TWIN-PEG CMNTD FEM SM PMA
Type of Device
KNEE PROSTHESIS
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 Key17938124
MDR Text Key325677180
Report Number3002806535-2023-00351
Device Sequence Number1
Product Code NRA
UDI-Device Identifier05019279438228
UDI-Public(01)05019279438228(17)320417(10)726180
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 Study,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/23/2023
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? No
Device Operator Lay User/Patient
Device Model NumberN/A
Device Catalogue Number161468
Device Lot Number726180
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/22/2023
Initial Date FDA Received10/16/2023
Supplement Dates Manufacturer Received10/20/2023
Supplement Dates FDA Received10/23/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/17/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
SEE H10 NARRATIVE.
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age52 YR
Patient SexFemale
Patient Weight75 KG
Patient RaceWhite
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