MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG PROMOS REVERSE BODY DIA36/10MM NON-CEM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	75003720
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a promos reverse total shoulder replacement surgery was performed on an unspecified date, the patient arrived with the body of the implant disengaged due to a body screw breaking between the body and the stem.This event has been addressed via revision surgery on (b)(6) 2022.Patient's current health status is unknown.
Additional Manufacturer Narrative
It was reported that, after a promos reverse total shoulder replacement surgery was performed on an unspecified date, the patient arrived with the body of the implant disengaged due to a body screw breaking between the body and the stem.This event has been addressed via revision surgery on (b)(6) 2022.Patient's current health status is unknown.The device, used in treatment, was not returned for investigation.A product evaluation was not possible.No batch number was communicated so the document history review was not possible.A complaint history review was performed.The occurrence of the reported failure mode is anticipated with a low risk level as per risk management.Due to insufficient information it is not possible to perform a review of past corrective actions.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.Insufficient information was made available to determine the revision of the instructions for use applicable to the device at the time of manufacturing.However, a review of current revision was conducted and it revealed that the instructions for use (lit.No.12.25, ed.07/10) states fracture of the implant and dislocation as ¿possible side effects¿ in combination with the implantation of a shoulder prosthesis.Based on the clinical information provided, the clinical root cause of the reported implant screw breakage and reverse body component disengagement cannot be definitively concluded.Due to this limited clinical information, no further clinical/medical assessment can be rendered at this time.Based on the information provided to the complaint, the reported failure mode could be confirmed.But based on the performed investigation, the root cause of the reported issue remains undetermined.It is not possible to investigate whether the reported device met manufacturing specifications upon release for distribution.Due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported event.There is no need for corrective action because of the limited information provided.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.

• Brand Name: PROMOS REVERSE BODY DIA36/10MM NON-CEM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15626381
• Report Number: 9613369-2022-00580
• Device Sequence Number: 20379377
• Product Code: KWS
• UDI-Device Identifier: 07611996087512
• UDI-Public: 7611996087512
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K081016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 75003720
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 11/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Male