MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR METAL-BACK (TI6AL4V + POROTI) METAL-BACK SMALL-R; KWS

Model Number 1375.21.005

Device Problems Component Falling (1105); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 06/25/2015

Event Type  Injury  

Event Description

Smr reverse implanted on (b)(6) 2015.Revision surgery on (b)(6) 2015 due to metal back + glenosphere coming off (as a single piece) from the glenoid bone.Surgeon replaced the whole prosthesis.The event occurred in (b)(6).

Manufacturer Narrative

By event description, no mechanical failure of the prosthesis (metal back and glenosphere were well fixed one each other when came loose from glenoid bone).This has been confirmed by a radiologic evaluation and by some photos of the explants returned.Explants not returned.No anomalies detected by checking the dhr of the metal back and glenosphere involved.No other complaints received on these lot # (metal back: (b)(4) pieces manufactured; glenosphere: (b)(4) pieces manufactured).Additional findings by x-rays evaluation: in the x-ray dated (b)(6) 2015 (immediate post-op), whole construct of mb + glenosphere appears to be already partially out of the glenoid bone (in the superior part); this suggests a suboptimal implant technique.The x-ray dated (b)(6) 2015 shows that the whole construct completely came out from the bone.Probable cause of the incident: suboptimal implantation technique, maybe combined with inadequate bone support to sustain the loads of the system mb + glenosphere.As reported by smr surgical technique: "the bone stock of the glenoid and humerus must be able to support the implant.In cases with significant bone loss and in which adequate fixation on the glenoid side cannot be obtained, a hemi with cta head should be performed." pms data: revision rate associated to this event is 0.034%; the majority of similar events was due to improper implantation or patient trauma / bone condition.No corrective actions.(b)(4) corporate will keep the market monitored to promptly detect possible recurrence of such event.Device not returned.

• Brand Name: SMR METAL-BACK (TI6AL4V + POROTI) METAL-BACK SMALL-R
• Type of Device: KWS
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; san daniele del friuli, udine 3303 8; IT 33038
• Manufacturer (Section G): LIMACORPORATE S.P.A.; IT
• Manufacturer Contact: giulio puppa ; IT
• MDR Report Key: 4952913
• MDR Text Key: 18094206
• Report Number: 3008021110-2015-00031
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 09/30/2019
• Device Model Number: 1375.21.005
• Device Lot Number: 201407833
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2014
• 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
• Patient Age: 74 YR