MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. VERSYS ADVOCATE FEMORAL STEM CEMENTED 12/14 OFFSET SIZE 14 135 MM; PROSTHESIS, HIP

Catalog Number	00785001400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Burning Sensation (2146); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial hip procedure.Subsequently, the patient is experiencing pain, swelling, burning sensation and has a nickel allergy.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: cat# 00877503602 lot# 3111383 biolox⮠delta, ceramic femoral head, m, 㸠36/0, taper 12/14 cat# 010000663 lot# 7216453 g7 pps ltd acet shell 52e.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} updated: a1; b2; b5; d4; g3; h2; h3; h4; h6 proposed code: mechanical (g04) ¿ stem no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed: an initial right tha was performed.Patient reported via telephone that she is experiencing swelling from her hip to foot.Doctor placed patient on prednisone which did not help the swelling.Patient states her hip is irritated with a burning groin pain and no other problems with the hip.Patient had an allergy test performed and a positive reaction to nickel and palladium.The root cause of the reported issue is attributed to user error, as the patient had a positive reaction to nickel present in the stem.As per ifu, it states zimmer is not liable for complications that may arise from use of the device in circumstances outside of zimmer¿s control including, but not limited to, product selection and deviations from the device¿s indicated uses or surgical technique.It is also noted that ¿metal sensitivity¿ is listed under the known ¿adverse effects¿ section which should be considered during product selection.As the liner, screws, and centralizer does not contain nickel/palladium, it would not have contributed to the allergic reaction symptoms, no problem was found with the devices.Based on the medical record review, the complaint is 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 further reported through patient's medical records that the patient was experiencing swelling form her hip to her foot.Patient developed cellulitis over bilateral ankles and was prescribed benadryl.The swelling continued.Patient was diagnosed with venous stasis dermatitis and prescribed a water pill for lymphedema.Patient has been using compression wraps and walks with a walker due to the swelling.Doctor prescribed patient prednisone which did not help with the swelling.Patient stated that her hip is irritated with burning groin pain.Patient had an allergy test done and had a positive reaction to nickel and palladium.

• Brand Name: VERSYS ADVOCATE FEMORAL STEM CEMENTED 12/14 OFFSET SIZE 14 135 MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21228367
• Report Number: 0002648920-2025-00025
• Device Sequence Number: 18228001
• Product Code: JDI
• UDI-Device Identifier: 00889024138193
• UDI-Public: (01)00889024138193(17)320425(10)65299522
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K950312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

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
• Device Catalogue Number: 00785001400
• Device Lot Number: 65299522
• 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: 01/07/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female