MAUDE Adverse Event Report: BIOMET UK LTD. CER OPT TYPE 1 TPR SLEVE 0MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problems Bacterial Infection (1735); Failure of Implant (1924); Necrosis (1971); Metal Related Pathology (4530)

Event Date 04/28/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - medical devices: cer bioloxd option hd 28mm; item# 650-1055; lot# 3062016.Unk 10.0 standard offset taper loc (sic) stem; item# unknown; lot# unknown.Unk biomet magnum size 52 outer diameter cup; item# unknown; lot# unknown.Bearing 28 x 46mm; itemx unknown; lot# unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00409.3002806535 - 2023 - 00410.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported a patient underwent a left hip revision approximately two years post implantation due to an infection.During the revision, a pseudo membrane, metallic fragments, and abnormal tissue including necrosis was noted.All the implants were removed and replaced with spacers.Approximately four months later, the spacers were removed and replaced with zb implants without complications.Attempts have been made and no further information is available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Devices are used for treatment.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 following iso/aami/astm & eu published guidelines.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.Medical records were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues.Removed pseudomembrane and any metallic fragments.Decompressed a large amount of murky fluid from the psoas sheath.Drain placed.Thoroughly irrigated and debrided the wound until we felt that all infected, necrotic, metallic, and abnormal tissue had been removed.With the available information, a definitive root cause could not be determined.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: CER OPT TYPE 1 TPR SLEVE 0MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• 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: 18254616
• MDR Text Key: 329550724
• Report Number: 3002806535-2023-00410
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00887868271489
• UDI-Public: (01)00887868271489(17)281214(10)2959147
• 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: Consumer,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• 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: 650-1066
• Device Lot Number: 2959147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2018
• 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): Hospitalization; Required Intervention
• Patient Sex: Female