MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR HUMERAL HEAD Ø46 MM; SMR HUMERAL HEAD Ø46 MM (KWT, HSD)

Model Number 1322.09.460

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Muscular Rigidity (1968); Pain (1994)

Event Date 06/20/2019

Event Type  Injury  

Manufacturer Narrative

By checking the manufacturing and sterilization charts of all the components involved, no anomaly was found.Therefore, we can ensure that all the components have been properly sterilized before being placed on the market.We will submit a final mdr once the investigation will be concluded.

Event Description

Revision surgery due to stiffness and pain occurred on (b)(6) 2019.Primary surgery was performed on (b)(6) 2018.According to the info reported, patient developed pain and stiffness post shoulder replacement and surgeon suspected of frozen shoulder.During revision, the following components were explanted: 1322.09.460, smr humeral head ø46 mm, lot #1807290, ster.1800194.1330.15.274, smr ecc.Adaptor taper standard, lot #1807534, ster.1800206.1350.15.010, smr trauma hum.Body # medium, lot #1807964, ster.1800214.Surgeon downsized head and thickness and changed the humeral body.Event occurred in (b)(6).

Manufacturer Narrative

Dhr check: by checking the manufacturing of all the components involved, no anomaly was found on the: - (b)(4) humeral heads belonging to lot# 1807290; - (b)(4) humeral bodies belonging to lot# 1807964; - (b)(4) adaptor tapers belonging to lot# 1807534.Therefore, we can state that these components had been manufactured up to specs, no deviation detected.Moreover, this is the first and only complaint received on these lots.Explants analysis: explants were not available to be returned to limacorporate for investigation.Xrays analysis: we received x-rays taken after primary surgery (exact date unknown) and forwarded them to our medical consultat for a clinical evaluation.He commented: "that is disappointing.The only comment one can make is there is the impression that the glenoid component is in slight upwards tilt.That in itself would not necessarily cause the outcome experienced.The implant otherwise seems uncomplicated with appropriate sizing and position of components.As always a painful stiff outcome of arthroplasty the possibility of infection is considered.".Conclusion: based on our analysis, this event seems to be not product-related, however no definitive conclusion on the root cause of pain and stiffness can be drawn.The surgeon responsible for both the surgeries, commented that the stiffness and pain were likely related to a frozen shoulder and maybe due to the oversizing of the head implanted during primary surgery.Nevertheless, our medical consultant did not confirm that the previously implanted femoral head was of a suboptimal size.According to his opinion, infection should be taken into consideration, but our complaint source stated that no infection was present.Considering that: -no infection was present, -the suboptimal components choice was not confirmed, -the surgeon responsible for the surgeries hypothesized frozen shoulder, -explants were not available to be returned to lima.We cannot define a clear root cause for the event but we can speculate it was related to suboptimal choice of components initially implanted and/or to patient's condition.Case not product related.No specific action for this case, limacorporate will continue monitoring the market to promptly detect any future similar event pms data:according to our pms data, estimated revision rate of smr anatomic total prosthesis, due to pain/stiffness/reduced rom is 0.11%.If we exclude the cases where the root cause was related to patient's rotator cuff failure, the specific revision rate is very low: 0.05%.

Event Description

Revision surgery of a smr anatomic total prosthesis due to stiffness and pain occurred on (b)(6) 2019.Primary surgery was performed on (b)(6) 2018.According to the info reported, patient developed pain and stiffness post shoulder replacement and surgeon suspected it was due to frozen shoulder.During revision, the following components were explanted: - 1322.09.460, smr humeral head ø46 mm, lot #1807290, ster.1800194; - 1330.15.274, smr ecc.Adaptor taper standard, lot #1807534, ster.1800206; - 1350.15.010, smr trauma hum.Body # medium, lot #1807964, ster.1800214.The glenoid metal back and the stem previously implanted were left in situ.According to the info received, the surgeon implanted a smaller size femoral head.Surgeon responsible for revision surgery (same as the one responsible for previous surgery) commented that he could have possibly oversized the femoral head during the previous surgery and this may have contributed to restriction experienced in active motion.Event happened in new zealand.

• Brand Name: SMR HUMERAL HEAD Ø46 MM
• Type of Device: SMR HUMERAL HEAD Ø46 MM (KWT, HSD)
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 8734265
• MDR Text Key: 149251574
• Report Number: 3008021110-2019-00074
• 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: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1322.09.460
• Device Lot Number: 1807290
• Date Manufacturer Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention