MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT SM SIZE 3 PMA; UNICONDYLAR KNEE PROSTHESIS

Model Number N/A

Device Problems No Device Output (1435); Appropriate Term/Code Not Available (3191)

Patient Problem Death (1802)

Event Date 07/06/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.Concomitant medical products: medical product: oxf uni tib tray sz c rm pma, catalog #: 154723, lot #: 2423675.Medical product: oxf twin-peg cmntd fem sm pma, catalog #: 161468, lot #: 2234831.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00291, 3002806535-2020-00293.Occupation: clinical knee admin.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported by the clinical study group that they received notification that patient who was enrolled in the oxford ide had died on (b)(6) 2019 due to unknown reasons.The patient underwent surgery on (b)(6) 2014 and received the control device (cemented oxford).The death was not device related.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00291-1, 3002806535-2020-00293-1.As the product has not been received, the investigation was limited to the information provided.Radiographs: -fourteen radiographs were provided for analysis with (b)(4), one anteroposterior (ap) and one mediolateral (ml) for each follow-up visit at 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years.Only radiographs showing the right knee (associated with complaint (b)(4)) have been assessed.-all provided radiographs of the right knee show adequately sized and positioned components of the oxford partial knee system.-at the pre-operative visit ((b)(6) 2014), the patient presented weight of 72.6 kg and a height of 1.63 m, thus having a bmi of 27.33 (overweight).-the kss and oxford assessment scores were excellent at post-operative visits, except from a slightly lower oxford knee score of 36 at the 3-year postoperative visit ((b)(6) 2017).It is to be noted that the patient reported an adverse event, described as patient fell on right knee about a month ago, she has mild posterior knee pain and weakness after the fall, about a month before this visit (date of onset (b)(6) 2017).-therefore, this adverse event may have contributed to the observed lower oxford knee score.Moreover, this adverse event was marked as not related to the device by the physician, and the event was recorded as tolerated with no treatment.-based on the radiographs provided with (b)(4) and on the information reported in the case report form (crf), it is concluded that the reported patient death is unrelated to the oxford knee system associated with the complaint.The manufacturing history records (mhrs) for the oxford anatomic bearing, tibial tray and femoral component have been checked and verify that the parts were manufactured and sterilised in accordance with the applicable specifications, and no abnormalities or deviations reporte.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: -the details of the reported event conclude that the reported death of the patient is unrelated to the device.-therefore, risk assessment cannot be conducted with the information provided.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.H3 other text : product has not been returned.

Event Description

It was reported by the clinical study group that they received notification that patient who was enrolled in the oxford ide had died on (b)(6) 2019 due to unknown reasons.The patient underwent surgery on (b)(6) 2014 and received the control device (cemented oxford).The death was not device related.

• Brand Name: OXF ANAT BRG RT SM SIZE 3 PMA
• Type of Device: UNICONDYLAR KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10178347
• MDR Text Key: 195895723
• Report Number: 3002806535-2020-00292
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 159568
• Device Lot Number: 129880
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEEH10.; SEEH10.
• Patient Outcome(s): Death
• Patient Age: 79 YR
• Patient Weight: 73