MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP SHELL POSITIONER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	75023819
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/28/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a total hip replacement intervention, the cup fell out of the tight cup holder.It fell to the floor.The incident occurred during the procedure.According to the sales rep, this event happened due to a handling mistake.To complete the procedure, a larger size was milled for a t59 cup because there was no other t57 cup in stock.There were no further consequences for the patient and the procedure was not delayed.
Additional Manufacturer Narrative
Results of investigation: it was reported that during a total hip replacement intervention, the cup fell out of the tight polarcup shell positioner.According to the complainant, the incident occurred during the procedure and happened due to a handling mistake.The device intended for use in treatment was not returned for investigation nor has a batch number been communicated.An appropriate investigation could therefore not be conducted and the reported failure mode could not independently be confirmed.It was noted that there were no further consequences for the patient and the procedure was not delayed.The use of another device during the procedure was not a result of mal-performance of the implant, but a result of the initial implant falling onto the floor.Further clinically relevant supporting documentation was not provided; therefore, a thorough medical investigation could not be performed.The surgical technique guide (01620-en (1582) v6.1 06/19) describes the correct handling of the polarcup shell positioner.Based on available information the root cause for the reported issue cannot be determined.The need for corrective action is not indicated.Smith + nephew will continue to monitor this device for similar issues.The complaint will be reopened should the complained device or additional information be received.
Event or Problem Description
It was reported that during a total hip replacement intervention, the cup fell out of the tight cup holder.It fell to the floor.The incident occurred during the procedure.According to the sales rep, this event happened due to a handling mistake.To complete the procedure, a larger size was milled for a t59 cup because there was no other t57 cup in stock.Hence, additional bone was reamed to fit the available cup.There were no further consequences for the patient and the procedure was not delayed.
Additional Manufacturer Narrative
Updated results of investigation: it was reported that during a total hip replacement intervention, the cup fell out of the tight polarcup shell positioner.According to the complainant, the incident occurred during the procedure and happened due to a handling mistake.The device intended for use in treatment was not returned for investigation nor has a batch number been communicated.However the polarcup shell (75100443) involved in the reported issue was received for investigation.The flanges have been removed.Apart from that, no visual damage could be observed.The fixation of the polarcup shell on the shell positioner and trial insert was tested and confirmed to work as intended.However, without the actual contributing devices (shell positioner & trial insert) the root cause for the malfunction cannot be determined.It was noted that there were no further consequences for the patient and the procedure was not delayed.The use of another device during the procedure was not a result of mal-performance of the implant, but a result of the initial implant falling onto the floor.Further clinically relevant supporting documentation was not provided; therefore, a thorough medical investigation could not be performed.A review of the risk management documentation verifies the failure mode and severity of the reported issue.The surgical technique guide (01620-en (1582) v6.1 06/19) describes the correct handling of the polarcup shell positioner.Based on available information the root cause for the reported issue cannot be determined.The need for corrective action is not indicated.Smith + nephew will continue to monitor this device for similar issues.The complaint will be reopened should the complained shell positioner or additional information be received.The received polarcup shell will be discarded.

• Brand Name: POLARCUP SHELL POSITIONER
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 9659782
• Report Number: 9613369-2020-00018
• Device Sequence Number: 401174
• Product Code: LPH
• UDI-Device Identifier: 07611996115451
• UDI-Public: 07611996115451
• Combination Product (Y/N): N
• PMA/510(K) Number: K122244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/07/2026
• Device Model Number: 75023819
• Device Catalogue Number: 75023819
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 01/15/2020; 07/07/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 04/13/2020; 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SHELL 75100443, LOT B1900443; SHELL 75100443, LOT B1900443
• Outcome Attributed to Adverse Event: Required Intervention