MAUDE Adverse Event Report: LIMACORPORATE S.P.A LINER F.MET.BACK GLEN.STANDARD

Model Number 1377.50.010

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hypersensitivity/Allergic reaction (1907); Implant Pain (4561)

Event Date 12/10/2016

Event Type  Injury  

Manufacturer Narrative

Checking the manufacturing charts for sterilization of the involved lot #s, no pre-existing anomalies were found.This is the first and only complaint received on these lot #s.The explanted items involved were not available to be returned to limacorporate for further analysis.No additional details were available on this post-operative issue, preoperative or post-operative x-rays were requested but not available.Based on the very few information received, we are not able to further investigate the root cause of the event.However, considering the facts: checking sterilization on the manufacturing charts of the involved lot #s, no pre-existing anomalies were found.Surgeon suspected cause was polyethylene allergy.We can state that the event was not product related.Pms analysis: (b)(4).This is the first complaint for suspected polyethylene allergy for smr anatomic total prosthesis.Based on the root cause analysis performed and according to the relevant pms data, no corrective actions required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issues.Note: this is a combined initial-final mdr.

Event Description

On (b)(6) 2016, shoulder revision surgery 1st revision for pain and potential allergy to polyethylene - conversion from anatomic to hemi-arthroplasty glenoid baseplate, screws, and polyethylene glenoid liner were removed.No issues with stability or fixation of the implant.Removed on assumption that cause was polyethylene allergy.Glenoid anatomy was bone grafted.Surgery history: (b)(6) 2016 - initial surgery: a lima smr anatomic total prosthesis was implanted.(b)(6) 2016 - 1st revision surgery due to pain and potential allergy to polyethylene or metal (surgeon concern).Conversion from anatomic to hemi prosthesis.This event was registered by limacorporate as complaint (b)(4).Object of this incident report patient data: male, date of birth - (b)(6) 1971, approx.Weight - 113kg, disabled.Event happened in u.S.Items explanted: smr humeral head ø48 mm, commercial codeb1322.09.480 - lot #1315297 - ster.#1300352.Smr ecc.Adaptor taper standard, commercial code 1330.15.274 - lot #1508213 ster.#1500401.Smr glenoid peg tt s/std/l #m, commercial code 1375.14.662 - lot #1520286 - ster.#1600016.Smr glenoid baseplate standard, commercial code 1375.15.610 - lot #1517501 - ster.#1600020.Liner f.Met.Back glen.Standard, commercial code 1377.50.010 - lot #15at1x3 - ster.#1600093.

• Brand Name: LINER F.MET.BACK GLEN.STANDARD
• Type of Device: LINER F.MET.BACK GLEN.STANDARD
• 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: 17448531
• MDR Text Key: 320326923
• Report Number: 3008021110-2023-00089
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/02/2023

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 Model Number: 1377.50.010
• Device Lot Number: 15AT1X3
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male