MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER; HUMERAL HEADS (COCRMO) DIA.50MM

Model Number	1322.09.500
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	05/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: checking the manufacturing charts of the products removed in the revision surgery hereby reported, no pre-existing anomaly, that could have contributed to the adverse event, was found out.The manufacturer will submit the final mdr as soon as the investigation is complete.
Event or Problem Description
Revision surgery due to rotator cuff failure and wear of the liner performed on (b)(6) 2025.Patient needed a conversion from an anatomical implant to a reverse configuration.The rotator cuff had failed.Additionally, it was found that the liner had worn down in one of the corners.The following devices were removed and replaced by reverse components: - smr humeral head dia.50 mm (part code 1322.09.500, lot number 2001533, sterilization (b)(4)).- smr ecc.Adaptor taper standard (part code 1330.15.272, lot number 2002535, sterilization (b)(4)).- liner f.Met.Back glen.Large (part code 1377.50.030, lot number 18at1j9, sterilization (b)(4)).- smr finned humeral body (part code 1350.15.110, lot number 2004189, sterilization (b)(4)).Previous surgery performed on (b)(6) 2020.The following other components were implanted during the previous surgery: - smr metal-back glenoid large (part code 1375.21.030, lot number 1906101, sterilization (b)(4)).- smr cementless finned stem (part code 1304.15.210, lot number 1922729, sterilization (b)(4)).The patient is a male, date of birth january 28th, 1955.The event happened in the united states.
Event or Problem Description
Revision surgery due to rotator cuff failure and wear of the liner performed on may 19th, 2025.Patient needed a conversion from an anatomical implant to a reverse configuration.The rotator cuff had failed.Additionally, it was found that the liner had worn down in one of the corners.The following devices were removed and replaced by reverse components: smr humeral head dia.50 mm (part code 1322.09.500, lot number 2001533, sterilization 2000135).Smr ecc.Adaptor taper standard (part code 1330.15.272, lot number 2002535, sterilization 2000086) liner f.Met.Back glen.Large (part code 1377.50.030, lot number 18at1j9, sterilization 1800387) smr finned humeral body (part code 1350.15.110, lot number 2004189, sterilization 2000129) previous surgery performed on august 14th, 2020.The following other components were implanted during the previous surgery: smr metal-back glenoid large (part code 1375.21.030, lot number 1906101, sterilization 1900242).Smr cementless finned stem (part code 1304.15.210, lot number 1922729, sterilization 2000042).The patient is a male, date of birth (b)(6)1955.The event happened in the united states.
Additional Manufacturer Narrative
Investigation: checking the manufacturing charts of the products removed in the revision surgery hereby reported, no pre-existing anomaly, that could have contributed to the adverse event, was found out.Based on the records available, at least 43 out of 62 items belonging to the part code 1322.09.500, lot number 2001533 and sterilization 2000135 have been implanted and at least 20 out of 32 items belonging to the part code 1377.50.030, lot number 18at1j9 and sterilization 1800387 have been implanted and this is the first and only complaint received on these lot numbers.We did not receive any additional information regarding this event, such as x-rays or pictures of the components explanted, therefore we are not able to carry out any further investigation.Hence, taking into account that: no pre-existing anomalies have been discovered by checking the manufacturing charts of the components belonging to the lot numbers 2001533 and 18at1j9.We have no evidence to consider the event as product related.Pms data: according to pms data, the revision rate of smr anatomic prosthesis (total and hemi) due to cuff failure is around 0.51%.Based on the root cause analysis performed and according to the relevant pms data, no corrective actions required for this specific case.The manufacturer continues monitoring the market to promptly detect any similar issue.Note: this is a final mdr.

• Brand Name: SMR SHOULDER
• Common Device Name: HUMERAL HEADS (COCRMO) DIA.50MM
• 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: 22381176
• Report Number: 3008021110-2025-00081
• Device Sequence Number: 9483234
• Product Code: KWT
• UDI-Device Identifier: 08033390001410
• UDI-Public: 08033390001410
• Combination Product (Y/N): N
• PMA/510(K) Number: K100858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

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?: Yes
• Device Model Number: 1322.09.500
• Device Lot Number: 2001533
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 07/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown