MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI PH3 FEMORAL IMPACTOR; KNEE ARTHROPLASTY

Model Number N/A

Device Problems Break (1069); Fracture (1260); Naturally Worn (2988)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Concomitant medical products: it has been indicated that the product is in process of being returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during impaction of the femur, the plastic of the impactor broke off and has to be replaced.Nothing fell into the patient and no harm was reported.Surgery completed without delay.

Event Description

It was reported that during impaction of the femur, the plastic of the impactor broke off and has had to be replaced.Nothing fell into the patient and no harm was reported.Surgery completed without delay.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.No product was returned; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, which was not provided.A review of complaint history was assessed for three years prior to the notification date and identified (8) similar complaints for item #32-420127 (including initiating complaint).A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any additional information becomes available, then the complaint will be reopened and further investigated.H3 other text: product not returned.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d4, g3, g6, h1, h2, h3, h6, h10.Visual examination of the returned product identified deformation at the edges of the impaction area, numerous scratches and gouges over the surface of the impaction area and small fractures at the edge of impaction surface.The instrument has potentially been in the field for approximately 3 years and 1 month.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Device is used for treatment.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.

• Brand Name: OXF UNI PH3 FEMORAL IMPACTOR
• Type of Device: KNEE ARTHROPLASTY
• 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: 12532044
• MDR Text Key: 274233632
• Report Number: 3002806535-2021-00403
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279477333
• UDI-Public: (01)05019279477333(11)190902(10)Z19G1770
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 32-420127
• Device Lot Number: Z19G1770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1