MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 36MM; CERAMIC FEMORAL HEAD PROSTHESIS

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Impaired Healing (2378)

Event Date 10/31/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: medical product: cer option type 1 tpr sleve +3, catalog #: 650-1067, lot #: 2954556, medical product: arcos 15x175mm brch body std, catalog #: 11-303015, lot #: 316650, medical product: arcos con sz a hi 60mm, catalog #: 11-301311, lot #: 869550.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00108.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent initial hip surgery.Subsequently, a revision was performed due to dislocation and delayed healing.

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: 3002806535-2020-00108-1.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, we have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.The sterilisation certificates were reviewed and confirmed that the product is sterilised within the specification range.A review of the complaint database over the last 3 years has found 1 similar complaint for this item code 650-1057 and 2 similar complaints found for the item 650-1067.There were no trends identified from the complaint history review.No same lot numbers, no same hospitals and there are no trends in the cause.Without the opportunity to examine the complaint product, the root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

Event Description

It was reported that the patient underwent initial hip surgery.Subsequently, a revision was performed due to dislocation and delayed healing.

• Brand Name: CER BIOLOXD OPTION HD 36MM
• Type of Device: CERAMIC FEMORAL HEAD PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9779177
• MDR Text Key: 182001904
• Report Number: 3002806535-2020-00107
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K082996
• 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: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 650-1057
• Device Lot Number: 2958840
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2020
• Initial Date FDA Received: 03/03/2020
• Supplement Dates Manufacturer Received: 04/23/2020
• Supplement Dates FDA Received: 04/30/2020
• 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: 68