MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CER FEM HD 32/+3MM T1; HIP PROSTHESIS

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Joint Dislocation (2374)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported by the hospital that a patient underwent initial tha.Subsequently, an x-ray identified a dislocation of the head.Revision surgery was conducted to replace the liner and head.

Event Description

It was reported by the hospital that a patient underwent initial tha.Subsequently, an x-ray identified a dislocation of the head.Revision surgery was conducted to replace the liner and head.

Manufacturer Narrative

(b)(4).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.

• Brand Name: DELTA CER FEM HD 32/+3MM T1
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8905256
• MDR Text Key: 154705129
• Report Number: 3002806535-2019-00688
• Device Sequence Number: 1
• Product Code: LZO
• 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
• Report Date: 09/16/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-1161
• Device Lot Number: 2018081128
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/22/2019
• Initial Date FDA Received: 08/19/2019
• Supplement Dates Manufacturer Received: 09/16/2019
• Supplement Dates FDA Received: 09/16/2019
• 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