MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA OPTION HEAD, 32MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Catalog Number	650-1056
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Purulent Discharge (1812); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: unknown biolox taper +3 neck lot# unknown unk biomet shell lot# unknown unk liner lot# unknown unk biomet stem lot# unknown 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 the patient underwent an initial right total hip arthroplasty on an unknown date.Approximately five months post-implantation, the patient underwent a revision due to three recurrent dislocations.Approximately nine years after the initial procedure, a second revision was performed due to pain and ossification.Approximately eleven days after suture removal, the surgical wound opened a couple of inches after the patient got up to go to the bathroom.Subsequently, a debridement, antibiotics, and implant retention (dair) procedure was performed, and all implants were retained without intra-operative complication.The patient underwent dair, and the implants remained in place with no known complications reported.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, b5, g3, g6, h2, h6, and h10.The following section was corrected: h6 component code.Review of the reported event by a health care professional found: 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 more invasively with an irrigation and debridement (i&d) which promotes healing at the site and prevents further complications.If deeper exploration of the wound is warranted and the joint space is entered, a poly exchange is typically performed in conjunction with the i&d to clear out any debris, hematoma formation, or to prevent deep joint infection.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history record and complaint history will not be completed for limited-investigation complaints, as the product meets the applicable requirements.The root cause of the reported event was determined to be unrelated to the device.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 or Problem Description
No further information available at the time of this report.

• Brand Name: BIOLOX DELTA OPTION HEAD, 32MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23483962
• Report Number: 3002806535-2025-00528
• Device Sequence Number: 9648923
• Product Code: LZO
• UDI-Device Identifier: 00887868271380
• UDI-Public: (01)00887868271380(17)320413(10)3111543
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K200959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

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 Catalogue Number: 650-1056
• Device Lot Number: 3111543
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2022
• 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: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 104 KG