MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCREW SELF-TAPPING 6.5 MM DIA.30 MM; PROSTHESIS, HIP

Catalog Number	00625006530
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Fever (1858); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Skin Discoloration (2074); Deformity/ Disfigurement (2360); Ambulation or Postural Difficulties (2544); Unequal Limb Length (4534); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 56mm o.D.Size kk porous uncemented with multi-holes shell use with kk liners.Item: 00875705602.Lot: 64819064.Femoral head sterile product do not resterilize 12/14 taper.Item: 00801803601.Lot: 65142250.36mm i.D.Size kk elevated rim liner use with 56mm o.D.Size kk shell.Item: 00875201236.Lot: 64933610.Bone screw self-tapping 6.5 mm dia.20 mm length.Item: 00625006520.Lot: 65140227.Bone screw self-tapping 6.5 mm dia.25 mm length.Item: 00625006525.Lot: 65135465.Wagner sl revision stem 17/225.Item: 01.00102.217.Lot: 3080476.G2: india.The customer indicated that the product remains implanted; therefore, it will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a left hip revision approximately 1 year post implantation due to having pain and difficulty ambulating.Subsequently, the patient continued to experience pain, difficulty ambulating, swelling, and impaired healing.The patient alleges leg length discrepancy and a systemic allergic reaction to the implant coating.Additionally, the patient alleges that the posterior screw of the cup is migrating and penetrating the gluten muscles and causing femoral and sciatic nerve damage and neuropathy.No medical records have been provided thus far.No additional information available for the reported event.
Event or Problem Description
No additional information available for the reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; h2; h3; h4; h6; d10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient alleges that the coating on the continuum cup contains iodine which he is allergic to, and this iodine is mixing in his blood stream resulting in immunosuppressive plasma therapy and ivlg injections.-patient reports after revision surgery, experienced severe pain in the left thigh and hip joint to the knee with neuropathy and leg length discrepancy (emg) electromyography performed -revision surgeon told patient that initial surgeon caused nerve damage.-patient reports since revision has had difficulty ambulating, pain, swelling, stiff leg oozing blood and water (allergic wounds in legs and feet), itching, discoloration, low grade fever, disfiguration -radiology performed: noted that the posterior screw of implant was abutting since beginning of fixing, with the gluteal medius maximum and minimum muscle and then that killer screw gradually deeply inserted, causing damage to acetabular wall and gluteal region and then inserted in muscle pain and also caused the atrophy/lesion of gluteal minimum and maximus muscle¿ causing nerve damage -patient alleges systemic nerve damage due to oxidation and implant reaction facing revision or amputation.A definitive root cause cannot be determined.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 trends.

• Brand Name: BONE SCREW SELF-TAPPING 6.5 MM DIA.30 MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• 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: 23542026
• Report Number: 0001822565-2025-04104
• Device Sequence Number: 21153254
• Product Code: LPH
• UDI-Device Identifier: 00889024119826
• UDI-Public: (01)00889024119826(17)301027(10)64825892
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K934765
• 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: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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 Catalogue Number: 00625006530
• Device Lot Number: 64825892
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Male