MAUDE Adverse Event Report: LIMACORPORATE SPA SMR HUMERAL HEAD Ø50 MM; SMR HUMERAL HEAD Ø50 MM (KWT, HSD)

Model Number 1322.09.500

Device Problem Naturally Worn (2988)

Patient Problems Unspecified Infection (1930); Toxicity (2333); No Code Available (3191)

Event Date 05/23/2018

Event Type  Injury  

Manufacturer Narrative

No anomalies detected by checking the sterilization charts of all the lot# involved (smr stem lot# 201003699; smr humeral head ø50 mm, lot#200908346; adaptor taper, lot# 201003330; smr hum.Body, lot# 201001559; smr glenoid, lot# 201001341) on the overall number of pieces manufactured with these lot#, thus indicating that the products were correctly sterilized before being placed on the market.No other complaints received on these components.We will send a final emdr once the evaluation will be concluded.

Event Description

Shoulder revision surgery due to infection performed on (b)(6) 2018.According to the info reported: primary surgery due to trauma was performed on (b)(6) 2010.Smr anatomic was implanted during this surgery; revision surgery initially performed in an unknown date due to unknown issue.During this first revision surgery, surgeon removed only the l2 liner previously implanted causing the cocr head to articulate on the mb baseplate.Wear of components and metallosis were experienced; removal of all the components previously implanted during the revision surgery performed on (b)(6) 2018.Event happened in (b)(6).

Event Description

First stage of shoulder revision surgery due to infection performed on (b)(6)2018.According to the info reported: - primary surgery due to trauma was performed on (b)(6)201.Smr anatomic total was implanted during this surgery; - first revision surgery performed in an unknown date due to unknown issue.During this revision surgery, surgeon removed only the l2 liner previously implanted causing the cocr humeral head to articulate on the mb glenoid baseplate.Wear of components and metallosis were experienced; - removal of all the components previously implanted during the first stage revision surgery due to infection performed on (b)(6)2018.No info about a second stage revision performed and/or components eventually implanted.According to the info reported by complaint source, surgeon responsible for removing only the l2 liner previously implanted was not specialized in shoulder arthroplasty.Moreover, according to ahpra (australian health practitioner regulation agency), he was not legally able to practise.Event happened in australia.

Manufacturer Narrative

Unfortunately, very few info received about this case.Explants analysis: explants not available to be returned to limacorporate.According to the info reported, explants were disposed of as per hospital policy.X-rays analysis: no x-rays available.Check of dhr: no anomalies detected by checking the sterilization charts of all the lot# involved (smr stem lot# 201003699; smr humeral head ø50 mm, lot#200908346; adaptor taper, lot# 201003330; smr hum.Body, lot# 201001559; smr glenoid, lot# 201001341) on the overall number of pieces manufactured with these lot#, thus indicating that the products were correctly sterilized before being placed on the market.No other complaints received on these components.According to the info reported, surgeon responsible for the first stage revision due to infection performed on (b)(6)2018 was "shocked" and rather confused as to why the previous surgeon did not perform a conversion to a reverse shoulder implant.At this stage, by considering the very few info provided and based on the analysis we could perform, we can conclude that infection is not product-related.Wear of components and metallosis was experienced due to negligence of the previous surgeon (not legally able to practice) responsible for removing only the poly liner implanted on 23rd of august, causing a direct contact between the humeral head and the metal back glanoid baseplate.Pms data: we are aware of two cases (including this one) of experienced wear and metallosis of a cocr humeral head (used in smr anatomic total) belonging to the family 1322.09.Xxx on a total of (b)(4) cocr humeral heads sold ww since 2002.Specific revision rate of (b)(4).No corrective action for this specific case.Limacorporate will continue monitoring the market.

• Brand Name: SMR HUMERAL HEAD Ø50 MM
• Type of Device: SMR HUMERAL HEAD Ø50 MM (KWT, HSD)
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 7577166
• MDR Text Key: 110331066
• Report Number: 3008021110-2018-00046
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K100858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

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: Health Professional
• Device Model Number: 1322.09.500
• Device Lot Number: 0908346
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/07/2018
• Supplement Dates Manufacturer Received: 06/01/2018
• Supplement Dates FDA Received: 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention