MAUDE Adverse Event Report: LIMACORPORATE SPA LINER F.MET.BACK GLEN.STANDARD

Model Number 1377.50.010

Device Problems Naturally Worn (2988); Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problem Loss of Range of Motion (2032)

Event Date 04/01/2020

Event Type  Injury  

Manufacturer Narrative

Check of the dhr by checking the dhr of the lot#17at0ud, no pre-existing anomaly was detected on the 61 liners manufactured, therefore we can state that all the components were manufactured up to specifications.This is the first and only complaint received on this lot#.Explant analysis: explants were not available to be returned to limacorporate.However, picture of the explanted poly liner shows wear of the central peg.From the picture, it was not possible to perform any technical analysis.Xrays analysis: we received pre-operative xrays taken one day prior revision and sent them to our medical consultant for technical investigation.Following, his comment is reported: "the patient, a young, weight lifting heavily muscled male has the greatest potential for arthroplasty failure.I cannot criticize the technical procedure carried out.If the surgeon has acquainted the patient of the very high risk of failure during the consent process which i am sure they have then they have discharged their obligation to the patient.That said there is the possibility of strongly advocating against arthroplasty and considering alternative management including surgery.Both non metal and metal back prostheses will fail in these circumstances but the metal back has a higher risk.Sadly it was all predictable." according to our medical consultant, patient physical condition and activity level led to predictable failure of the prosthesis.We checked the instruction for use associated to the failed liner which clearly indicated that overweight and strenuous physical activities (active sports, heavy physical works) as risk factors.Considering the opinion of the medical consultant, the high bmi of the patient and the strenuous activity level he used to perform, we can conclude that root cause of the event is patient related.Event not product related.Pms data: according to our pms data, revision rate due to wear of the liner l1 standard code 1377.50.Xxx is 0.11%.None of these event was judged as product related.No corrective/preventive action implemented for this specific case.Limacorporate will keep the market monitored.Please, consider this mdr as an initial-final mdr.

Event Description

Revision surgery of smr anatomic system performed on (b)(6) 2020.Primary surgery was performed on (b)(6) 2017.Cause for revision was loss of range of motion and squeaking of the prosthesis.Symptoms were described as a sudden grinding or clunking of the prosthesis.During revision surgery, poly liner, humeral head and adaptor were replaced.The liner (product code 1377.50.010, lot #17at0ud, ster.1700245) was found to be worn, but still well positioned.It was reported that patient is (b)(6) years old, very fit and muscular.He is a weight lifter with a bmi of 54 (height was 1.55 m, weight was (b)(6) kg).

• Brand Name: LINER F.MET.BACK GLEN.STANDARD
• Type of Device: LINER F.MET.BACK GLEN.STANDARD
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: federica malvaso ; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 10070578
• MDR Text Key: 192196211
• Report Number: 3008021110-2020-00032
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K113254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1377.50.010
• Device Lot Number: 17AT0UD
• Date Manufacturer Received: 05/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention