MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00875101036-liner neutral 36 mm i.D.Size ii for use with 52 mm o.D.Size ii shell-62661367.00875705202-shell with multi holes porous 52 mm o.D.Size ii for use with ii liners-61887857.00489405820- trabecular metal⿢ acetabular revision system acetabular augment-62199762.00877503602-biolox⮠delta, ceramic femoral head, m, 㸠36/0, taper 12/14-2705086.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 02269.0001822565 - 2020 - 02270.

Event Description

It was reported the patient is experiencing femoral pain, stiffness of the hip joint, and occasional hip pain approximately five years post implantation.Surgeon indicated to the patient that the femoral pain was not due to the implant, that the implant appeared to be fine.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b7; g4; h2; h3; h6 reported event was confirmed via medical records reviewed by a health care professional.No product was returned; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the event.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.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10205666
• MDR Text Key: 196831797
• Report Number: 0001822565-2020-02271
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K192660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00771101320
• Device Lot Number: 62258721
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Other
• Patient Age: 68 YR