MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCR 6.5X50 SELF-TAP; PROSTHESIS, HIP

Catalog Number	00625006550
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Unequal Limb Length (4534)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A2: birth year 1972.D10: cat# 110010268 lot# 7257034 g7 osseoti multihole 60mm g.Cat# 11-107017 lot# 66030715 freedom constr hd 36mm t1 -3mm.Cat# 11-301342 lot# 408860 arcos con sz b std 80mm.Cat# 11-300818 lot# 573860 arcos 18x150mm spl tpr dist.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.
Event or Problem Description
It was reported that the patient underwent a previous hip revision where zb product was implanted.Subsequently, the patient is experiencing pain approximately 9 months post implantation.The devices remain implanted, and patient has been referred for non-surgical treatment options.No intervention has been reported to date.Attempts have been made, and no further information has been provided.
Event or Problem Description
It was further reported the patient was experiencing worsening left hip, groin, buttock and thigh pain, limited daily activities, and mild limp starting approximately 2 months post-implantation.The patient was also noted to have some edema to the foot.The surgeon provided a shoe lift to the patient for leg length discrepancy and patient continued physical therapy; however, this did not provide any relief.The surgeon referred the patient to an orthotist for a custom shoe.Patient also provided flector patch for pain.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.D10: unk synthes cable.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} updated: d4; g3; h2; h3; h6 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 provided and reviewed by a health care professional.Review of the available records identified the following: attending pt, muscle spasms of left thigh and intermittent left groin pain.Patient feels pt works her too hard.Worsening left hip pain; mild limp, patients states hip feels like it did previously when infected.Pain in left leg/groin; continue therapy and shoe lift ordered.Severe pain, that limits activities/pain meds ; slight limp, walks 6 blocks.No abnormal findings with implant imaging.Shoe lift for lld not assisting with pain relief.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 for trends.
Event or Problem Description
No further information at the time of this report.

• Brand Name: BONE SCR 6.5X50 SELF-TAP
• 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 MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22435147
• Report Number: 0002648920-2025-00179
• Device Sequence Number: 19991547
• Product Code: LPH
• UDI-Device Identifier: 00889024119857
• UDI-Public: (01)00889024119857(17)240630(10)62754325
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K934765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2025

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: 06/30/2024
• Device Catalogue Number: 00625006550
• Device Lot Number: 62754325
• 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: 06/13/2025
• Supplement Date Received by Manufacturer: 07/23/2025; 10/20/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 07/30/2025; 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2014
• 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: Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White