MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA CER OPTION HD 40MM; PROSTHESIS, HIP

Catalog Number	650-1058
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Post Operative Wound Infection (2446)
Date of Event	05/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - associated medical devices: cer option type 1 tpr sleve -6; item# 650-1064; lot# 843540.G7 finned 4 hole shell 54f; item# 110017104; lot# 3737138.G7 hi-wall e1 liner 40 mm f; item# 010000942; lot# 3722429.Tprlc 133 t1 pps so 10 x 140 mm; item# 51-103100; lot# 3216783.G7 screw 6.5 mm x 25 mm; item# 010000998; lot# 3709227.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.
Event or Problem Description
It was reported that the patient underwent an initial right total hip arthroplasty.Subsequently, 1 month post-implantation the patient underwent an irrigation and debridement (i&d) procedure due to drainage from the right hip.During the i&d, a subcutaneous hematoma with purulent appearance was identified; however, there was no communication with the hip joint.The joint was not entered, and all components remained implanted.Attempts have been made and no further information has been provided at the time of this report.
Event or Problem Description
No additional event information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.Corrected: h6 (component code).A hematoma is a mass of clotted blood that forms in a tissue, organ, or body space.A hematoma can be associated with pain, swelling, ecchymosis, serosanguinous or bloody drainage after a recent surgical procedure or trauma and can predispose the patient to infection.The development of postoperative hematoma can be correlated with the surgical procedure and perioperative anticoagulation therapy prescribed to prevent thrombus formation.Most hematomas resolve on their own, without surgical intervention, while some do not.Larger hematomas may need to be surgically evacuated to resolve.As timeframes of onset differ due to individual contributing factors, a specific timeframe of expected occurrence cannot be established.It is expected that a wound heals in stages and should be of normal appearance related to the timeframe since the incision was made.A surgical wound should be well approximated without redness, warmth, swelling and/or purulent drainage for the duration of its healing.The expression "wound concerns" or "non-healing wound" would imply that the appearance of the wound deviates from what a surgical wound should appear.It may be red, have drainage, additional pain, warmth and swelling as well as healing time may be delayed.This deviation signifies an alteration in the wound healing process which can be complicated by patient comorbidities such as diabetes, obesity, smoking, and other conditions that are known to slow a person's ability to heal.Wound complications can be treated conservatively or invasively depending on the severity of the wound infection and patient status.The reported event of superficial infection occurred at 30 days post implantation.Superficial infections are considered a procedure related complication as no device has been reported as revised.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.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations, further eliminating the implanted devices as a potential source for the reported infection.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.As devices have not been indicated as revised and there are no indications of product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection.No product was returned or pictures provided visual and dimensional evaluations could not be performed.The root cause of the reported event was determined to be unrelated to the device.This device is used for treatment.This is a limited investigation, a review of the device history record and complaint history review will not be completed for limited investigation complaints as the product meets the applicable acceptance criteria.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.

• Brand Name: BIOLOX DELTA CER OPTION HD 40MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23756438
• Report Number: 3002806535-2025-00569
• Device Sequence Number: 9521283
• Product Code: LZO
• UDI-Device Identifier: 00887868271403
• UDI-Public: (01)00887868271403(17)221031(10)771480
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K200959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 650-1058
• Device Lot Number: 771480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Female
• Patient Weight: 142 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White