MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS STS DIST STEM 16X250MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Loss of or Failure to Bond (1068); Migration (4003)

Patient Problems Ossification (1428); Pain (1994); Ambulation Difficulties (2544); Unequal Limb Length (4534)

Event Date 01/25/2022

Event Type  Injury  

Event Description

It was reported underwent a left hip revision approximately 4 years post implantation due to pain, loosening, and subsidence of the femoral stem resulting in leg length discrepancy, antalgic gait, and pedestal formation in the femur.During the procedure the head, cone, and stem were revised.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).Concomitant products: 11-363664- 36mm cocr mod hd +6mm- 668770.11-363664- 36mm cocr mod hd +6mm- 709590, customer has indicated that the product will not be returned to zimmer biomet for investigation, product location unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported underwent a left hip revision approximately 4 years post implantation due to pain, loosening, and subsidence of the femoral stem resulting in leg length discrepancy, antalgic gait, and pedestal formation in the femur.During the procedure the head, cone, and stem were revised.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed via medical records reviewed by a health care professional.Visual examination of the returned product identified the stem is still assembled with the neck and shows significant signs of use.There are several areas of bone cement on the porous coated surface.There are also discolorations along the flutes of the stem.No other damage noted on the stem.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported 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.

Event Description

No additional information on the reported event.

• Brand Name: ARCOS STS DIST STEM 16X250MM
• 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: 13541367
• MDR Text Key: 285672877
• Report Number: 0001825034-2022-00360
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 0088030447453
• UDI-Public: (01)0088030447453(17)260809(10)173860
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/24/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-301016
• Device Lot Number: 173860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 02/16/2022
• Supplement Dates Manufacturer Received: 03/21/2022
• Supplement Dates FDA Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 86 KG