MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX CER OPTION TYPE 1 TPR SLEVE -3; 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: 650-1057 ¿ biolox ceramic head ¿ 620880.13-104060 ¿ 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 - 00079.

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.

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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.D10 : ref 11-301112 lot 170660 arcos brch sz b hi 60mm; ref 11-301412 lot 158390 arcos 12x115mm cyl dist; ref 13-104060 lot 793250 m/h radial solid/apx shl 60mm; ref ep-105995 lot 346300 epoly 36mm rlc lnr mrom sz25 ze 25; ref 650-1057 lot 620880 biolox head 36mm-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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records, raw material certs and sterile certs confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint histories identified additional similar complaints for the reported items and no additional similar complaints for the reported part and lot combinations.Medical records were provided and reviewed by a health care professional.The review identified that the patient experienced chronic recurrent lateral hip pain and revision was conducted for infection.Further, the root cause of the event of infection is not device related.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, implanted products are not identified as the source or contributing to the reported infection.A definitive root cause could not be determined for the pain.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 CER OPTION TYPE 1 TPR SLEVE -3
• 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: 18811059
• MDR Text Key: 336591256
• Report Number: 3002806535-2024-00078
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00880304521940
• UDI-Public: (01)00880304521940(17)250717(10)835650
• 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,Followup
• Report Date: 06/26/2024

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: 650-1065
• Device Lot Number: 835650
• 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; 06/24/2024
• Supplement Dates FDA Received: 04/02/2024; 06/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2015
• 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): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 116 KG
• Patient Ethnicity: Non Hispanic