MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA OPTION CERAMIC HEAD 36MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Fall (1848); Bone Fracture(s) (1870); Hemorrhage/Bleeding (1888); Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); Muscle/Tendon Damage (4532); Insufficient Information (4580)

Event Date 07/22/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: 650-1065 biolox taper sleeve ¿ 835650 13-104060 ¿ m/h shell ¿ 793250 ep-105995 ¿ epoly liner ¿ 346300 11-301412 ¿ arcos distal stem ¿ 620880 unknown arcos cone ¿ unknown part and lot 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.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2024 - 00078.

Event Description

It was reported that patient underwent a revision surgery approximately 7 years post implantation.Subsequently, the patient was revised a second time approximately 7 years later due to unknown reasons.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.D10 : ref: (b)(4), lot: 170660 arcos brch sz b hi 60mm.Ref: (b)(4), lot: 158390 arcos 12x115mm cyl dist.Ref: (b)(4), lot: 793250 m/h radial solid/apx shl 60mm.Ref: (b)(4), lot: 346300 epoly 36mm rlc lnr mrom sz25 ze 25.Ref: (b)(4), lot: 835650 cer option type 1 tpr sleve -3.Cerament bone filler, item: unknown, lot: unknown.Unknown cement, item: unknown, lot: unknown.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

It was reported by legal allegations that a patient had an initial left total hip arthroplasty approximately sixteen years ago followed by a revision about seven years post implantation due metal related pathology.Subsequently, the patient had a chronic trochanteric avulsion fracture and developed pain, stiffness, range of motion issues, and a fall that led to ongoing diagnostic tests with suspicion of alval.Approximately two years ago, the patient underwent a stage i revision for infection.During the procedure, a small fracture of the anterior cortex occurred from the wedging of the osteotome, the patient experienced blood loss, all implants were removed, and a competitor cement spacer was implanted.Stage ii revision followed one and a half months later with competitor product implanted.Attempts have been made and no further information has been provided.

• Brand Name: BIOLOX DELTA OPTION CERAMIC HEAD 36MM
• Type of Device: PROSTHESIS, HIP
• 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: 18811063
• MDR Text Key: 336591275
• Report Number: 3002806535-2024-00079
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00887868271397
• UDI-Public: (01)00887868271397(17)250731(10)620880
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 650-1057
• Device Lot Number: 620880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/29/2024
• Supplement Dates Manufacturer Received: 03/05/2024
• Supplement Dates FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• 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.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 116 KG
• Patient Ethnicity: Non Hispanic