MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD MOD HD 36MM +3 NK; HIP ARTHROPLASTY

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Wound Dehiscence (1154); Joint Dislocation (2374)

Event Date 03/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded.Medical product: liner standard 3.5 mm offset 36 mm i.D.For use with 56 mm o.D.Shell, catalog #: 00630505636, lot #: 64588657.Medical product: bone screw self-tapping 6.5 mm dia.35 mm length, catalog #: 00625006535, lot #: 64323444.Medical product: bone screw self-tapping 6.5 mm dia.25 mm length, catalog #: 00625006525, lot #: 63010467.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent a right tha.Subsequently, a revision surgery was performed due to dislocation and wound dehiscence.

Manufacturer Narrative

(b)(4).Summary: as the product has not been received, the investigation was limited to the information provided.In addition, we have not been provided with any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.The sterilisation certificate was reviewed and confirmed that product is sterilised within the specification range.A review of the complaint database over the last 3 years has found no similar complaints reported with the item 12-115122.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: linked complaint managed by zb warsaw (b)(4) has reviewed surgical notes provided.It is noted that a contributing factor of the issue that led to a revision is that the patient lost balance and fell while trying to dry feet getting out of the shower.The reason for the patients fall and lack of balance was not established in the linked complaint.Since the root cause of the reported event could not be determined with the information provided to date a specific hazard within the i/o table could not be selected for assessment.However, the harm of dislocation as a potential outcome is documented for a number of hazards and is considered as a severity score of 3 - moderate, which is defined as per the severity table within the rmr as prescribed medical or surgical intervention to preclude permanent impairment.Therefore the outcome of this complaint is considered to be in line with the anticipated outcome of dislocation.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.

Event Description

It was reported that a patient underwent a right tha on march 9, 2020 by (b)(6).Subsequently, the patient was revised due to dislocation and wound dehiscence on march 29, 2020 by (b)(6).

• Brand Name: CER BIOLOXD MOD HD 36MM +3 NK
• Type of Device: HIP ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10086150
• MDR Text Key: 194809846
• Report Number: 3002806535-2020-00252
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00887868248498
• UDI-Public: 00887868248498
• Combination Product (y/n): N
• PMA/PMN Number: K061312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2020
• Device Model Number: N/A
• Device Catalogue Number: 12-115122
• Device Lot Number: 2986019
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/12/2020
• 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
• Patient Weight: 89