MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP TYPE1 PPS HO 14.0; PROSTHESIS, HIP

Model Number N/A

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 07/01/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 110017108 ¿ g7 shell ¿ 64849765; 30123608 ¿ g7 vit e liner ¿ 64849765; 650-1057 ¿ biolox head ¿ 3062933; 650-1067 ¿ biolox taper ¿ 307230.Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent a left hip revision approximately 9 months post implantation due to progressive pain.During the surgery, it was noted that the stem appears to have potted due to excessive pps spray at the reduced distal portion of the stem.The stem and head were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

H6: component code mechanical (g04) ¿ stem.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: overall implant fit and alignment are anatomic.Bone quality appears normal.No signs of malalignment, loosening, or wear.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.A summary of the investigation was requested and sent to the customer.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

Event Description

No additional event information to report at this time.

• Brand Name: TPRLC 133 MP TYPE1 PPS HO 14.0
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15091878
• MDR Text Key: 296468524
• Report Number: 0001825034-2022-01700
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304513518
• UDI-Public: (01)00880304513518(17)300623(10)6806775
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• 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: 51-107140
• Device Lot Number: 6806775
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2020
• 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: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male