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

Model Number N/A

Device Problems Difficult to Insert (1316); Activation, Positioning or Separation Problem (2906); Positioning Problem (3009)

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

Event Date 12/07/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00532.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported, that: surgeon was about to implant the dual mobility head construct, two piece 28mm head with +6 sleeve.The head construct would not fill the trunnion of the stem.Trailed with a one piece head trial and the trial did fill the trunnion.Patient outcome: no further information.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information: patient initials, date of birth, age at time of the event, concomitant medical products.Medical product:650-1068, catalog #: cer option type 1 tpr sleve +6, lot #:3063682; medical product: 51-104170, catalog #: tprlc 133 t1 pps ho 17x154mm, lot #:6883347.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00532-1.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported, that: surgeon was about to implant the dual mobility head construct, two piece 28mm head with +6 sleeve.The head construct would not fill the trunnion of the stem.Trialed with a one piece head trial and the trial did fill the trunnion.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay supplemental information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10.Complaint summary: a review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.A review of complaint history identified 5 additional similar complaints about the reported item and no additional complaints about the reported item and lot combination.A visual inspection shows handling marks and light scratches in the adapter taper consistent with assembling with the hip stem.Otherwise, the head and the tapered adapter appear to be in good condition.A dimensional inspection shows the internal taper on the tapered adapter (item 650-1068 lot.3049624) which interfaces the hip stem taper to be conforming to the drawing specification.This device is used for treatment.A review of the associated product taperloc complete 17 high offset.Part number 51-104170, lot 6883347 shows it is a type 1 taper so is compatible with the tapered adapter 650-1068 / lot.3063682.It has been confirmed that the implant is not within the scope or subject of any field actions or recalls which could be attributed to the reported events.The likely condition of the device when it left zimmer biomet is conforming to the specification.The reported event has not been confirmed.Dhr review did not identify any issues.The definitive root cause of this event cannot be determined with the available information; however, as the tapered adapter (item 650-1068 lot.3063682) is conforming to specification it is not related to the reported event.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2021-00532-2 if any additional information is discovered or received that may adjust any conclusions or data, a supplemental report will be rendered accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported, that: the surgeon was about to implant the dual mobility head construct, a two-piece 28mm head with a +6 sleeve.The head construct would not fill the trunnion of the stem.Trialled with a one-piece head trial and the trial did fill the trunnion.Patient outcome: no further information.Addi (b)(6) 2022.Dob (b)(6) 1958.Activity level: unknown.I need to know what stem was being used when this occurred? this could potentially be another complaint.Was it a zb stem? do you have the part/lot number? the stem was a taperloc complete 17 high offset.Part number 51-104170, lot 6883347.

• 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: 13024791
• MDR Text Key: 287811033
• Report Number: 3002806535-2021-00531
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00887868271373
• UDI-Public: 00887868271373
• 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: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2022

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: 3087106
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/17/2021
• Supplement Dates Manufacturer Received: 01/13/2022; 03/30/2022
• Supplement Dates FDA Received: 01/18/2022; 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2021
• 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
• Treatment: SEE H10 COMMENTS
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 116 KG