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

Model Number	N/A
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Activation Problem (4042)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/06/2016
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3002806535-2022-00095
• Device Sequence Number: 19319012
• Product Code: LZO
• UDI-Device Identifier: 00887868271397
• UDI-Public: 00887868271397
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K192683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 03/19/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2015
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown