MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RINGLOC BI-POLAR HIP SYSTEM; PROSTHESIS, HIP

Catalog Number	11-165244
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Codes	Insufficient Information (4580); Aseptic loosening (4883)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: unk zimmer biomer bipolar head; unk depuy ultima stem.G2: foreign ¿ poland.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a hip procedure due to the cup products not working.The cup was explanted and a provisional big head mounted on stem to prevent further proximal migration.A custom triflange component has been requested.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 information.The following sections were updated: a2; a3; a4; b5; b7; d4 lot; d6a; d10; g3; h2; h6 d10: cat # unk lot # 696440 zimmer biomet bipolar head.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a right hip surgery due to trauma and late loosening of the cup.The cup was explanted on an unknown date and a provisional big head mounted on the stem to prevent further proximal migration.A custom triflange has been requested for lack of bone stock.A full revision is planned but has not taken place to date.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 information.The following sections were updated: d4 cat number, udi, expiry date; g3; g4; h2.The following sections were corrected: d1; d4 lot number.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b5; b7; d10; g3; h2; h3; h4; h6 d10: cat# 802202804 lot # 3145138 femoral head 12/14 taper 28 mm diameter +7 mm neck length; unk depuy ultima stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined, however it is known that a zb head was used with a competitor stem and this is considered off label use per ifu it states, "only authorized combinations should be used¿ and ¿do not use components with components of any other system or manufacturer, unless authorized by zimmer biomet.¿ "zimmer biomet or its affiliates are not liable for complications that may arise from use of the device in circumstances outside of zimmer biomet¿s or its affiliates control including, but not limited to, product selection and deviations from the device¿s indicated uses or surgical technique." during follow-up it was noted the patient had fell down the stairs.It is also noted patient has a history of substance abuse.It is not known what caused the patient to fall, and whether this caused or contributed to the reported event.As per the ifu it states; "failure of the patient to follow postoperative care instructions involving rehabilitation can compromise the success of the procedure.The patient is to be advised of the limitation of the reconstruction and the need for protection of the implants from full load bearing until adequate fixation and healing have occurred.Excessive, unusual and/or awkward movement and/or activity, trauma, excessive weight, and obesity have been implicated with premature failure of certain implants by loosening, fracture, dislocation, subluxation and/or wear.Loosening of the implants can result in increased production of wear particles, as well as accelerate damage to bone making successful revision surgery more difficult." complaint is not confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the patient underwent a right hip surgery due to trauma and late loosening of the cup.The patient fell on the stairs leading to traumatic cup loosening.The cup was explanted on an unknown date and a provisional big head mounted on the stem to prevent further proximal migration.A custom triflange has been requested for lack of bone stock.A full revision is planned but has not taken place to date.Attempts have been made and no further information has been provided.

• Brand Name: RINGLOC BI-POLAR HIP SYSTEM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23108736
• Report Number: 0001825034-2025-02964
• Device Sequence Number: 13285824
• Product Code: JDI
• UDI-Device Identifier: 00880304209831
• UDI-Public: (01)00880304209831(17)260121(10)696440
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K051569
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/10/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/21/2026
• Device Catalogue Number: 11-165244
• Device Lot Number: 696440
• 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: 09/08/2025
• Supplement Date Received by Manufacturer: 11/12/2025; 01/14/2026; 02/19/2026
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 12/09/2025; 01/27/2026; 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2021
• 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 Age: 78 YR
• Patient Sex: Male
• Patient Weight: 90 KG