MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PKS HIGH FLEX TWIN PEG CEMENTED FEMUR - XSMALL; KNEE PROSTHESIS

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)

Event Date 04/30/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical devices: oxf anat brg rt x-sm 4mm pma item# 160791 lot# 6741836.Oxf uni tib tray sz d rm pma item# 154725 lot# 6937758.Report source: foreign - china.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.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2022 ¿ 00319, 3002806535 - 2022 ¿ 00321.

Event Description

It was reported that the patient underwent a revision procedure of the right knee approximately three (3) months post implantation due to pain, swelling and limitation of movement after extreme flexion of the knee.Due diligence is in progress for this complaint; to date no additional information or product has been received.

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 information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Devices are used for treatment.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: overall fit and alignment are maintained, there is no sign of loosening.No dislocation is identified on the images.However, a dislocation could certainly cause symptoms such as pain and swelling and the need for a revision.The root cause of the reported issue is attributed to patient non compliance based upon the information provided by the surgeon and supported by the operating surgeon's assessment.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.

• Brand Name: OXFORD PKS HIGH FLEX TWIN PEG CEMENTED FEMUR - XSMALL
• 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 Key: 15052330
• MDR Text Key: 296140015
• Report Number: 3002806535-2022-00320
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 00887868354830
• UDI-Public: (01)00887868354830(17)300804(10)6839631
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 166940
• Device Lot Number: 6839631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female