MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CEMENTED STEM Ø12 MM; CEMENTED HUMERAL STEMS L.80MM DIA.12MM,

Model Number 1306.15.120

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Date 11/10/2021

Event Type  Injury  

Manufacturer Narrative

By the check of the device history records, no pre-exiting anomaly that could have contributed to the issue was found on the components that were released on the market with the lot number involved (1509240).No other similar complaints were received on this lot number.We will submit a final report after the conclusion of the investigations.

Event Description

Shoulder revision surgery due to loosening of the stem (smr cemented stem ø12 mm code 130615120 lot 1509240) performed on (b)(6) 2021.According to the information received, the plan was to implant a custom-made device, due to an intra-operative issue (reported to fda: ref.3008021110-2021-00094) the surgeon had to convert to hemi prosthesis.Patient is male, (b)(6) old.Event occurred in (b)(6).

Manufacturer Narrative

By the check of the device history records, no pre-exiting anomaly that could have contributed to the issue was found on the components that were released on the market with the lot number involved (1509240).According to our records, at least 49 stems belonging to production lot number 1509240 have already been implanted and no other complaints were received on them.Additional information was repeatedly requested to the complaint source, however the following details were never received: - x-rays to allow a clinical evaluation by a medical consultant, - details on the reported humeral fractures and any trauma experienced by the patient, to evaluate if they could have contributed to the loosening, - patient data such as activity level/relevant clinical condition, - date of the previous surgery.The explanted devices were not available to be returned to limacorporate, due to hospital policy.We only received few pictures of the explanted devices.Following the evaluation of these images, we noted a possible discrepancy between the visible devices and the product codes indicated by the complaint source, however the codes/lots are not visible on the photos and the complaint source was not able to retrieve additional information in order to confirm or correct the data provided.Without the possibility to analyze the explanted devices nor the x-rays, no investigation can be performed, other than the check of the device history records, which confirmed that the involved stems lot number was manufactured up to drawing specifications and in line with the relevant checks and tests.Based on the check of the device history records, this event is classified as not product-related.Pms data based on limacorporate pms data, we estimate a revision rate of smr cemented stems (family codes 1306.15.Xxx) of about 0.01%.No corrective action needed following this complaint.Limacorporate will keep monitoring the market to promptly detect any further similar event.

Event Description

Shoulder revision surgery due to loosening of the stem (smr cemented stem ø12 mm code 1306.15.120, lot 1509240) performed on (b)(6) 2021.The complaint source reported that the implants were implanted 60 months before revision, the exact date is not available.A custom-made device was implanted during revision surgery.According to the information received, during the revision surgery, an intra-operative issue occurred (reported to fda: ref.3008021110-2021-00094) upon removal of the glenosphere, the metal back glenoid came out and disassembled from the peg.Consequently, the surgeon had to convert to hemi prosthesis (composed by the custom-made humeral component and the humeral head).The complaint source reported that initially the metal back appeared well fixed and they did not plan to revise it.However, when the implants came out, the surgeon commented on the lack of bone ingrowth.The patient is male, born in 1939, multiple humeral fractures reported.This event occurred in uk.

• Brand Name: SMR CEMENTED STEM Ø12 MM
• Type of Device: CEMENTED HUMERAL STEMS L.80MM DIA.12MM,
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via naizonale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 12878085
• MDR Text Key: 281279401
• Report Number: 3008021110-2021-00095
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1306.15.120
• Device Lot Number: 1509240
• Is the Reporter a Health Professional?: No
• 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