MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN LINER; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Fracture (1260); Malposition of Device (2616)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 09/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign.The event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient was revised due to eccentric poly bearing wear and the presence of a foreign body as seen on x-ray.Intra-operatively, a small metal ring of unknown origin was identified and removed.No further information has been made available at this time.

Manufacturer Narrative

This report is being submitted to relay additional information.The following sections have been updated: the following sections have been corrected: device was implanted on unknown day in 2006 item # 00642803201, alumina ceramic femoral head, lot # unk contact phone number complaint sample was evaluated and the reported event was confirmed.As returned, the liner is severely damaged from explanting.The rim feature is partially fractured.The backside surface exhibits deep gouging.Damage is too severe for dimensional analysis.The reported event was confirmed with the review of radiographs.From the x-ray review : curvilinear metallic focus seen inferior to the femoral neck on the ct.Finding is also seen in this same location on the plain films.Radiolucency noted along the proximal femoral stem.Contour irregularity of the superior acetabular cup.There is a right total hip arthroplasty in place superficially seated within the right femur.There is radiolucency along both sides of the proximal femoral stem.There is irregularity of the appearance of the entire acetabular cup with evidence of acetabular liner loosening and hardware disassembly.Curvilinear metallic focus inferior to the femoral neck is present with mild bony fragmentation , possibly heterotopic ossification.Streak artifact does limit evaluation.The acetabular liner may be fractured inferiorly.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause unable to be determined.A summary of the investigation has been sent to the complainant.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 Description

No further event information available at the time of this report.

• Brand Name: UNKNOWN LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7243627
• MDR Text Key: 99093473
• Report Number: 0001822565-2017-08407
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN PART/LOT, BIOLOX FEMORAL HEAD; UNKNOWN PART/LOT, FEMORAL STEM COMPONENT; UNKNOWN PART/LOT, ZIMMER TRILOGY 48MM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 39 YR
• Patient Weight: 84