MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCREW SELF-TAPPING 6.5 MM DIA. 50 MM LENGTH; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Catalog Number	00625006550
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.
Event or Problem Description
No further information at the time of this report.
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; h4; h6 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: ¿ pta on the left with evident graft anchored with screws filling the roof gap (pseudo-pemberton).Necessary sinking of the cup itself with anchored metal back.¿ ambulated with crutches with gradual weight bearing.After a short walk with weight bearing, onset of pain in the left lower limb.¿ ¿outcomes of reimplantation of left coxo-femoral arthroprosthesis and of bone grafting of the acetabular floor with presence of fixation screws and on the iliac bone; bone harvesting presumably corresponding to the left ischiopubic branch with signs of consolidation.An apparent rarefaction of the bone region grafted on the acetabular floor is observed.Unchanged sclerosis of the left sacroiliac joint.More evident asymmetry of the iliac crests, with the right more elevated than the contralateral side by about 10 mm.Marked right-convex lumbar scoliosis.¿ ¿ ¿at the site of the left coxofemoral prosthetic reimplantation, predominantly fluid collection with mild peripheral capsular calcifications tending to surround the prosthesis, with greater expression on the posterior side, extending for about 12 cm craniocaudally, with a laterolateral diameter of over 6 cm and an anteroposterior diameter of 9 cm.A predominantly fluid collection is also detectable in the pelvic region, involving the left iliopsoas and measuring approximately 4 × 3 × 4 cm.The prosthesis also appears somewhat protruded toward the acetabulum, with rarefaction and wear of the reimplant performed on the acetabular floor.¿ ¿ voluminous periprosthetic fluid collection extending mainly posteriorly, with extension toward the iliopsoas.Resorption of the graft at the roof level and clear progression of protrusion.¿ 160 cc of serohematic fluid; no signs of infection.¿ emergency department visit for a syncopal episode with subsequent aphasia.Husband reported therapy with parathyroid hormone for a few days.¿ left hip pain.¿ two units of prbcs administered due to anemia secondary to a thigh hematoma.¿ vena cava filter placement.Temporary placement of a vena cava filter due to lower-extremity dvt.¿ acetabular revision.¿ visible and palpable tense, elastic swelling in the gluteal region, consistent with a large hematoma.¿ the cup had migrated and sunk into the pelvis and was removed.No signs of osteointegration were present on the surface in contact with the bone.Total absence of the anterior wall and acetabular floor was noted.¿ venous bleeding was noted from the acetabular floor and repaired by a vascular surgeon.The vascular surgeon and interventional radiology were alerted before surgery for this purpose.¿ three units of prbcs and two units of plasma were transfused intraoperatively.¿ intraoperative cultures were negative.¿ good stability, with a positive limb-length discrepancy of 2 cm.This was not captured because it represented an improvement from prior imaging, which displayed a 10 mm discrepancy before the revision.Review of the reported event by a health care professional found: the root cause of the blood loss and hematoma was determined to be unrelated to the device.A definitive root cause cannot be determined for the pain.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.

• Brand Name: BONE SCREW SELF-TAPPING 6.5 MM DIA. 50 MM LENGTH
• Common Device Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
• 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: 25182885
• Report Number: 0002648920-2026-00069
• Device Sequence Number: 10703063
• Product Code: LPH
• UDI-Device Identifier: 00889024119857
• 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: 00625006550
• Device Lot Number: 63913605
• 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: 03/16/2018
• 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