MAUDE Adverse Event Report: LIMACORPORATE S.P.A HPS TIBIAL LINER #4 H10

Model Number 6539.54.410

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/05/2023

Event Type  malfunction  

Manufacturer Narrative

Checking the manufacturing charts of the involved lot #2124032 no pre-existing anomalies were found.Of the 12 total components manufactured with this lot# this is the first and only complaint received on this lot #.We will send final report after the investigation is complete.

Event Description

During a knee primary surgery performed on (b)(6) 2023, hps tibial liner #4 h10, commercial code 6539.54.410, lot # 2124032 - ster.#2200149 implant would not seat.The surgeon tried to remove debris (if it existed) from the plate and for some reason it was always loose.A size 11 settled on in the end to complete the surgery.Another size 10 was not available during surgery.15 min delay to try the implant several times and switch to another implant.Surgeon was happy with the results in the end.He likes the ps and hps options.Patient - female.Date of birth - (b)(6) 1955.Event happened in the u.S.

Event Description

During a knee primary surgery performed on (b)(6) 2023, hps tibial liner #4 h10, commercial code 6539.54.410, lot # 2124032 - ster.#2200149 implant would not seat.The surgeon tried to remove debris (if it existed) from the plate and for some reason it was always loose.A size 11 settled on in the end to complete the surgery.Another size 10 was not available during surgery.15 min delay to try the implant several times and switch to another implant.Surgeon was happy with the results in the end.He likes the ps and hps options.Patient - female date of birth - (b)(6) 1955.Event happened in the u.S.

Manufacturer Narrative

Checking the manufacturing charts of the involved lot number 2124032 no pre-existing anomalies were found.Of the 12 total components in this manufactured with this lot number this is the first and only complaint received on this lot number.Explants and x-rays analysis: the component was returned for further investigation.The dimensions of the implantable device have been checked and found to be compliant with the drawings.A slight deformation on the tooth of the component has been found, but this is due to the multiple attempts to seat the implant during the surgery.In conclusion, considering that: - no anomaly was found by checking the manufacturing charts of the involved lot number.- the dimensions of the component have been found compliant with the drawings, except for a slight deformation on the tooth, due to the multiple insertions and extractions of the component.We can suppose that the issue was not product related pms data: based on the information available, this is the first complaint received so far about this kind of issue involving a hps tibial liner, product marketed from 2022.No specific corrective action is needed for this case.Limacorporate will continue monitoring the market to promptly detect any further similar issues.This is a final mdr.

• Brand Name: HPS TIBIAL LINER #4 H10
• Type of Device: HPS TIBIAL LINER #4 H10
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale, 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale, 52; villanova di san daniele, udine 33038
• MDR Report Key: 17254084
• MDR Text Key: 318473206
• Report Number: 3008021110-2023-00077
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K213381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 6539.54.410
• Device Catalogue Number: 6539.54.410
• Device Lot Number: 2124032
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/28/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Female