MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CER FEM HD 32/+6MM T1; KNEE PROSTHESIS

Model Number N/A

Device Problem Break (1069)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in the (b)(6).Concomitant medical products: medical product: stanmore lateral sz 4, catalog #: not reported, lot #: not reported; medical product: exceed cemented muller e1 60, catalog #: not reported, lot #: not reported.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 hip replacement procedure.Subsequently, a revision procedure was performed due to the ceramic femoral head fracturing.

Event Description

The hospital reported that a patient underwent an initial hip replacement procedure.Subsequently, a revision procedure was performed due to the ceramic femoral head fracturing.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 hip replacement procedure.Subsequently, a revision procedure was performed due to the ceramic femoral head fracturing.

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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Medical product: stanmore lateral sz 4 catalog #: 650-0943 lot #: 2041864.Medical product: exceed cemented muller e1 60 catalog #: ep-123260 lot #: 3864690.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 hip replacement procedure.Subsequently, a revision procedure was performed due to the ceramic femoral head fracturing.

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 hip replacement procedure.Subsequently, a revision procedure was performed due to the ceramic femoral head fracturing.

• Brand Name: DELTA CER FEM HD 32/+6MM T1
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8992411
• MDR Text Key: 157417312
• Report Number: 3002806535-2019-00740
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• 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: 650-1160
• Device Lot Number: 2019020673
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2019
• 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 Age: 70 YR
• Patient Weight: 88