MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PH3 CEMENTLESS FEM SZ S; KNEE PROSTHESIS

Model Number N/A

Device Problems Malposition of Device (2616); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 08/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a supplemental mdr will be submitted.Concomitant medical products: medical product: oxf uni cmntls tib sz b rm, catalog #: 166573, lot #: 6267378; medical product: oxford ph3 cementless fem sz s, catalog #: 154925, lot #: 6251421.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00681, 3002806535-2019-00683.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

The hospital reported that a patient underwent an initial knee replacement procedure.Subsequently, the patient experienced knee pain due to an infection, and as a result a revision procedure was performed.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

The hospital reported that a patient underwent an initial knee replacement procedure.Subsequently, the patient experienced knee pain, and as a result a revision procedure was performed.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, h1, h2, h3, h6, h10.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00681-2, 3002806535-2019-00683-2.Products have been returned to biomet uk ltd for evaluation and forwarded to the complaints product evaluation engineer for investigation.From the information provided it can be deduced that the implant was in service for approximately 1 year prior to revision.No device or manufacturing deficiencies have been identified that could cause the reported event.The complaint is not related to the function or performance of the device itself.The initial alignment of components, and hence the root cause, could not be assessed with the available information.However, as suggested by the surgeon, malalignment, which could have been caused by either the implant migration or miss-positioning during procedure, may have contributed to the early failure of the device.The following features are observed in the radiographs: medial overhang of the meniscal bearing, radiolucency underneath the tibial tray, the tibial tray appears to be short of the medial edge of the tibial plateau, femoral component appears to be positioned at an angle relative to the tibial component.The product left the company conforming.The manufacturing history records (mhrs) of the returned components have been checked and verify that the parts were manufactured and sterilised in accordance with the applicable specifications.A review of the complaint database over the last 3 years has found no similar complaints reported.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

The hospital reported that a patient underwent an initial knee replacement procedure.Subsequently, the patient experienced knee pain, and as a result a revision procedure was performed at hospital (b)(6).Sonication shows no infection.

• Brand Name: OXFORD PH3 CEMENTLESS FEM SZ S
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8895979
• MDR Text Key: 154407908
• Report Number: 3002806535-2019-00682
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 154925
• Device Lot Number: 6251421
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention