MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP SHELL TI-PLASMA/HA 45 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Model Number 75100437

Device Problems Fitting Problem (2183); Mechanical Jam (2983); Positioning Problem (3009); Physical Resistance/Sticking (4012)

Patient Problem Failure of Implant (1924)

Event Date 06/11/2021

Event Type  Injury  

Event Description

It was reported that a revision of a 40 mm pinnacle cup and exeter stem was performed due to instability.A 45 mm polar cup with screws and flanges was chosen.After trialing, it was decided pegs were necessary.First peg hole was removed uneventfully but the second became stuck after initially turning.Attempts to keep removing rounded the hex in cover.Eventually, hole cover was removed using midas rex causing a delay of 30 minutes or more.Cup was implanted, peg holes drilled and pegs impacted.Unfortunately the pegs didn¿t impact all the way in and were left proud.It was decided this was an unacceptable risk to the poly and cup was removed.Surgery was finished using a competitor's device.No patient harm reported.

Manufacturer Narrative

It was reported that a revision surgery of a cup and stem was performed due to instability.A polarcup shell ti-plasma/ha 45 non-cem (b)(6) was chosen.After trailing, it was decided that polarcup anchoring pegs (b)(6) were necessary.First peg cover was removed uneventfully but the second became stuck after initially turning.Attempts to keep removing rounded the hex in cover.Eventually, the hole cover was removed using midas rex causing a delay of 30 minutes or more.The cup was implanted, the peg holes drilled and pegs impacted.Unfortunately, the pegs didn¿t impact all the way in and were left proud.It was decided this was an unacceptable risk to the insert and cup was removed.Surgery was finished using a competitor's device.Both devices, intended for use in treatment, have not been returned for investigation.An evaluation of the complained devices could therefore not be conducted and the reported failure mode could not independently be confirmed.A medical investigation was conducted.However, based on the limited information provided, a thorough assessment could not be performed.A review of the complaint history revealed no other complaint being reported for the batch of the cup and the peg in question.A review of the batch record revealed no deviations from the standard manufacturing process that could have contributed to the reported failure mode.The surgical technique (lit no.(b)(4)) describes the correct removal of the polarcup plugs using the unidirectional t handle (b)(6)"release the plugs by turning the t wrench in the direction indicated on the plug cover." the ifu (lit.No.(b)(4)) states: "the following might not be implanted under any circumstances: implant components that have been damaged or scratched; implants that have been handled inappropriately or processed in a way that is not part of the surgical technique".The decision to mechanically remove the peg cover and use the implant for the patient is considered off label use and did most certainly contribute to the peg not being able to be fully impacted.The current risk analysis covers the risk of jamming between plug and shell.The associated risk level is considered low.Based on the performed investigations, the reported failure mode could not be confirmed.A relationship between the reported event and the devices cannot be confirmed.There is no indication that the reported devices failed to meet manufacturing specifications upon release for distribution.A worn t-handle is known to contribute to the reported event.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.(b)(4)), all devices must be inspected and controlled for proper functioning after cleaning/disinfection.Based on available information the root cause for the reported jamming between cup and cover (b)(6) cannot clearly be identified and stays undetermined.However, the root cause for the peg (b)(6) not being able to be fully impacted, is clearly associated to off label use.Based on the conducted investigation the need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor both devices for similar issues.The complaint will be reopened should additional information or one of the devices be received g2: report source update.

Manufacturer Narrative

H6: it was reported that a revision surgery of a cup and stem was performed due to instability.A polar cup shell ti-plasma/ha 45 non-cem (75100437) was chosen.After trailing, it was decided that polar cup anchoring pegs (75017231) were necessary.First peg cover was removed uneventfully but the second became stuck after initially turning.Attempts to keep removing rounded the hex.Eventually, the hole cover was removed using midas rex causing a delay of 30 minutes or more.The cup was implanted, the peg holes drilled and pegs impacted.Unfortunately, the pegs didn't impact all the way in and were left proud.It was decided this was an unacceptable risk to the insert and cup was removed.Surgery was finished using a competitor's device.Both devices, used in treatment, have been returned for investigation.A visual inspection confirmed the reported failure mode.The polar cup was returned with both pegs impacted and the two plugs removed.The plug which was mechanically removed is fully destroyed.Many dents and scratches are observed on the articulating surface.It stays undetermined if the damage occurred during the attempt to remove the jammed plug or during removal of the cup.A medical investigation was conducted.However, based on the limited information provided, a thorough assessment could not be performed.A review of the complaint history revealed no other complaint being reported for the batch of the cup and the peg in question.A review of the batch record revealed no deviations from the standard manufacturing process that could have contributed to the reported failure mode.The surgical technique (lit no.01620-en (1582) v7 10/20) describes the correct removal of the polar cup plugs using the unidirectional t handle (75023347): "release the plugs by turning the t wrench in the direction indicated on the plug cover." the ifu (lit.No.12.23 ed 03/21) states: "the following might not be implanted under any circumstances: implant components that have been damaged or scratched; implants that have been handled inappropriately or processed in a way that is not part of the surgical technique".The decision to mechanically remove the peg cover and use the implant for the patient is considered off label use and did most certainly contribute to the peg not being able to be fully impacted.The current risk analysis covers the risk of jamming between plug and shell.The associated risk level is considered low.Review of past corrective actions was performed.No further escalation is required.Based on the performed investigations, the reported failure mode could be confirmed.A relationship between the reported event and the devices was confirmed.There is no indication that the reported devices failed to meet manufacturing specifications upon release for distribution.A worn t-handle is known to contribute to the reported event.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all devices must be inspected and controlled for proper functioning after cleaning/disinfection.Based on available information the root cause for the reported jamming between cup and cover (75100437) cannot clearly be identified and stays undetermined.However, the root cause for the peg (75017231) not being able to be fully impacted, is clearly associated to off label use.Based on the conducted investigation the need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor both devices for similar issues.The returned devices will be retained.

• Brand Name: POLARCUP SHELL TI-PLASMA/HA 45 NON-CEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• 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: 12058774
• MDR Text Key: 258081408
• Report Number: 9613369-2021-00311
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 07611996118285
• UDI-Public: 07611996118285
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K122244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/24/2021

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 Operator: Health Professional
• Device Model Number: 75100437
• Device Catalogue Number: 75100437
• Device Lot Number: B2014034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2021
• Initial Date FDA Received: 06/24/2021
• Supplement Dates Manufacturer Received: 07/21/2021; 12/23/2021
• Supplement Dates FDA Received: 07/22/2021; 12/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2020
• 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): Hospitalization; Required Intervention