MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 28MM; BIOLOX DELTA CERAMIC OPTION HD

Model Number N/A

Device Problems Mechanical Problem (1384); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2021

Event Type  malfunction  

Event Description

It was reported, that: the surgeon initially planned to use the 50 mm, but decided that he could not use it because the e1 liner and head were stuck.The surgeon tried to use the 49mm instead, but the 49mm was even more immobile and could not be used.The surgeon finally blended in the 50mm before using it.Delay 0-15 minutes.

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).The product has been requested to be returned to zimmer biomet for investigation.Associated products: medical product: e1 ringloc bipolar 28x50mm, catalog no.: 110010470, lot no.: 266770.Medical product: e1 ringloc bipolar 28x49mm, catalog no.: 110010456, lot no.: 700730.Medical product: cer option type 1 tpr sleve -6, catalog no.: 650-1064, lot no.: 3065004.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: the product was returned for evaluation.The event occurred during surgery.Prolonged surgery.The device is used for treatment.The complaint could not be confirmed or recreated on review was the returned product appeared to be conforming to specification.Visual inspection did not show any damage to ceramic head.The head appeared to be in good condition without any visible signs of wear or damage.Dimensional check confirms that the ceramic head conforms to specification.Review of certificate of conformance confirms conformance to specification.Review of manufacturing history record confirms that the device & packaging was processed and verified in line with the specification and quality characteristics and was completed as defined by zimmer biomet.The goods acceptance document confirms the release of the order without any recorded non-conformances.The product item no.650-1055, lot: 3079978 has not been involved in any previous capas or field actions.No corrective actions are required at this time.A review of the risk management file will not be completed as the product meets the applicable acceptance criteria.The definitive root cause cannot be determined with the available information as the ceramic head was found to conform to specification on review.The investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and further investigated.

Event Description

Describe event or problem: it was reported, that: the surgeon initially planned to use the 50 mm, but decided that he could not use it because the e1 liner and head were stuck.The surgeon tried to use the 49mm instead, but the 49mm was even more immobile and could not be used.The surgeon finally blended in the 50mm before using it.Delay 0-15 minutes.

• Brand Name: CER BIOLOXD OPTION HD 28MM
• Type of Device: BIOLOX DELTA CERAMIC OPTION HD
• 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: 13287905
• MDR Text Key: 284012948
• Report Number: 3002806535-2022-00011
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00887868271373
• UDI-Public: 00887868271373
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K192683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-1055
• Device Lot Number: 3079978
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/04/2022
• Initial Date FDA Received: 01/19/2022
• Supplement Dates Manufacturer Received: 03/23/2022
• Supplement Dates FDA Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1