MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 36MM; BIOLOX DELTA CER OPT HD LG DIA

Model Number N/A

Device Problems Activation, Positioning or Separation Problem (2906); Activation Problem (4042)

Patient Problem Joint Dislocation (2374)

Event Date 09/06/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.The investigation is currently underway.Once the investigation has been concluded, a follow-up report will be submitted to relay the findings.

Event Description

It was reported, that: in medical notes received the patient underwent a closed reduction procedure approximately 7 months post-implantation due to dislocation.Subsequently, the patient underwent a second closed reduction procedure approximately 12 months post-implantation.The patient underwent a right hip revision procedure approximately 14 months post-implantation due to the reoccurring dislocation.During the procedure, the femoral head and acetabular liner were removed and replaced.Patient involvement - revision.

Event Description

It was reported, that: in medical notes received the patient underwent a closed reduction procedure approximately 7 months post-implantation due to dislocation.Subsequently, the patient underwent a second closed reduction procedure approximately 12 months post-implantation.The patient underwent a right hip revision procedure approximately 14 months post-implantation due to the reoccurring dislocation.During the procedure, the femoral head and acetabular liner were removed and replaced.Patient involvement - revision.

Manufacturer Narrative

No product was returned or pictures provided.Visual and dimensional evaluations could not be performed.The device history records for item # 650-1057 lot # 592710 were reviewed for deviations or anomalies with no anomalies or deviations identified.The device is used for treatment.The reported product was reviewed for compatibility with no issues noted.A complaint history review for item 650-1057 identified three (3) previous similar complaints.The likely condition of the devices when they left zimmer biomet is conforming to specification.The reported event has not been confirmed as the products have not been returned for evaluation and the dhr review did not identify any issues.The root cause of the reported event cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after the investigation of this event.

• Brand Name: CER BIOLOXD OPTION HD 36MM
• Type of Device: BIOLOX DELTA CER OPT HD LG DIA
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13692216
• MDR Text Key: 286743868
• Report Number: 3002806535-2022-00095
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00887868271397
• UDI-Public: 00887868271397
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/05/2022

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: 592710
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 03/08/2022
• Supplement Dates Manufacturer Received: 05/04/2022
• Supplement Dates FDA Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention