MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Catalog Number	00625006520
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Anemia (1706); Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Osteolysis (2377); Inadequate Osseointegration (2646); Unequal Limb Length (4534); Joint effusion (4849)
Date of Event	10/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# 00625006525 lot# 64894184 bone scr 6.5x25 self-tap.Cat# 00625006520 lot# j6900709 bone screw self-tapping 6.5 mm dia.20 mm length.Cat# 00625006520 lot# j6900709 bone screw self-tapping 6.5 mm dia.20 mm length.Cat# 00625006550 lot# 63913605 bone screw self-tapping 6.5 mm dia.50 mm length.Cat# 010000942 lot# 8807035 g7 hi-wall e1 liner 40mm f.Cat# 00877704002 lot# 3085487 biolox⮠option, head, m, 㸠40/0, taper 12/14.Cat# 01.00551.305 lot# 2480927 fitmor hip stem b ext offs s5.G2: foreign: italy.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.Subsequently, the patient was undergoing a slow progressive recovery and after a short walk with weight bearing, had an onset of pain.Radiographic imaging displayed a periprosthetic fluid collection, resorption of the graft, and cup protrusion.Patient underwent an ultrasound guided aspiration.A week later, presented to the emergency room and admitted to the hospital with hip pain, anemia, and hematoma within the iliopsoas muscle, and required blood transfusions during the hospitalization.Approximately 8 months post-implantation, underwent a revision where a large hematoma was evacuated, the cup migrated and was found without signs of osteointegration, and absence of the anterior and acetabular floor.During the procedure, an expected venous bleed from the acetabular floor was encountered and corrected by a vascular surgeon.Due to the blood loss, required intra-op and post-operative blood transfusions for hemodynamic stability.All implants, except the stem were revised.Following the surgery, the patient remained intubated within icu for a total of three days and then underwent an uneventful post-operative recovery and was discharged home.Attempts have been made and no further information has been provided.

• Brand Name: BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH
• Common Device Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• 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: 25182879
• Report Number: 0001822565-2026-01583
• Device Sequence Number: 10703060
• Product Code: LPH
• UDI-Device Identifier: 00889024119802
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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: 00625006520
• Device Lot Number: J6900709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Supplement Date Received by Manufacturer: 09/30/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2020
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 121 LB