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

Model Number 1377.50.010

Device Problem Naturally Worn (2988)

Patient Problems Necrosis (1971); Toxicity (2333)

Event Date 08/30/2018

Event Type  Injury  

Manufacturer Narrative

We will submit a final mdr once the investigation will be concluded.

Event Description

Shoulder revision surgery due to metallosis performed on (b)(6) 2018.Previous surgery performed on (b)(6) 2012.According to the info received, patient had necrosis and poly wear was present.No other info available.Event happened in (b)(6).

Manufacturer Narrative

Check of dhr: the check of the manufacturing chart of the l1 liner involved did not show any anomaly on a total of 32 components placed on the market with the same lot #1207107.More important, no other complaints reported on a total of 32 out of 32 liners l1 already implanted with the same lot#.Explants analysis: no explants nor pictures of the explants available for further analysis.X-rays analysis: x-ray images were not available for a clinical evaluation.With the only very few info provided, we cannot go back with certainty to the root cause of the event reported.By the analysis performed, this seems to be a case not product related.Pms data: we are aware of a total of 11 revisions of l1 liner due to wear on a total of 14537 l1 liners sold ww since 2002.This gives a specific revision rate of (b)(4).No corrective actions planned for this case.Limacorporate will keep monitored the market.

Event Description

Shoulder revision surgery performed on the (b)(6) 2018 due to severe poly wear of the l1 liner previously implanted in 2012 (code #1377.50.010, lot #1207107, ster.#1200208) and necrosis.According to the info reported, during current revision, the glenoid metal back was instead left in situ.Previous surgery occurred on the (b)(6) 2012.Event occurred in australia.

• 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
• MDR Report Key: 8004665
• MDR Text Key: 124981594
• Report Number: 3008021110-2018-00095
• 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,Followup
• Report Date: 05/09/2019

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?: No
• Device Operator: No Information
• Device Model Number: 1377.50.010
• Device Lot Number: 1207107
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention