MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 28/-3.5, TAPER 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED

Model Number N/A

Device Problem Positioning Problem (3009)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2022

Event Type  Injury  

Event Description

It was reported that during an initial hip procedure, after the surgeon had implanted the devices, the femoral head and the stem could not create taper locking; the fixation was unstable.This caused a surgical delay of 70 minutes; prolonged anesthesia time and increased blood transfusion.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).Concomitant medical products: liner assy 44/45/46od x 28id item# 00-5001-044-28 lot# 65445539.Femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 9 standard.Offset reduced neck length item# 00771100910 lot# 65353315.Report source¿ foreign ¿ china.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated:b4, b5, d9, g3, g6, h2, h3, h6, h10.Review of the provided intraoperative videos identified that the head was loose on the stem taper.No further evaluation can be made from the provided videos.Visual examination of the complained ceramic head identified significant metal smearing over most of the head taper, most likely deriving from intraoperative manipulations during assembly of the head and the stem.Below a prominent line and on the bottom of the taper no metal smearing can be seen, indicative of the area of contact between stem taper and head taper.Due to the significant metal smearing in the taper of the head, a reliable dimensional measurement of the head taper is no longer possible.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.Medical records were not provided.A definitive root cause cannot be determined for the head and stem not locking together.The increased blood transfusion/blood loss was determined to be procedure related after review by a health care professional.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.

Event Description

No further event information available at the time of this report.

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 28/-3.5, TAPER 12/14
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 16060081
• MDR Text Key: 306249092
• Report Number: 0009613350-2022-00680
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K071535
• 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: 04/13/2023

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: 00-8775-028-01
• Device Lot Number: 3119026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 04/05/2023
• Supplement Dates FDA Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• 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 NARRATIVE
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male