MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Scar Tissue (2060); Joint Dislocation (2374)

Event Date 07/18/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent left hip arthroplasty.Approximately 2 years later, a revision procedure was performed due to dislocation.During the revision procedure impingement and scar tissue were also noted.The cup, head, and liner were exchanged without any reported complications and no further information is known at this time.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).D10 - medical devices: g7 bonemaster ltd acet shl 56f; item# 010000705; lot# 6813056.Biolox delta cer lnr 36mm f; item# 110003623; lot# 6839566.G2 - foreign: australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.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.No product was returned, but two pictures were provided and assessed.The articulation surface and the bevel of the biolox head show some black metal smears, but are otherwise inconspicuous.The taper shows a regular seating pattern consisting of circumferential metal smears in the lower part of the taper.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Device is used for treatment.Medical records were provided and reviewed by a health care professional.The patient underwent a left tha due to osteoarthritis.Subsequently, the patient underwent a revision surgery due to dislocation.During the revision procedure impingement and scar tissue were also noted.Two x-rays from the initial surgery were provided and reviewed, however, they do not enhance the investigation of reported event in this complaint.With the available information a definitive root cause cannot be established.If any further information is found which would change or alter any conclusions or information, a supplemental report 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, M, 36/0, TAPER 12/14
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• 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: 17405683
• MDR Text Key: 319855556
• Report Number: 0009613350-2023-00421
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024430365
• UDI-Public: (01)00889024430365(17)301031(10)3047826
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K192416
• 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: 09/18/2023

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-036-02
• Device Lot Number: 3047826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/18/2023
• Initial Date FDA Received: 07/27/2023
• Supplement Dates Manufacturer Received: 09/15/2023
• Supplement Dates FDA Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2020
• 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; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female