MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP PE INSERT 49/28 NON-CEM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number 75017221

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994)

Event Date 11/12/2018

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, after a right thr revision surgery, where a polarcup pe insert 49/28 non-cem, was implanted, the patient underwent a revision surgery on (b)(6) 2018 to explant liner and head, due to unexplained pain and adverse soft tissue reaction to particulate debris.Current health status of the patient is unknown.This information was provided by the national joint registry of the united kingdom, as part of a retrospective data collection of patients who underwent either a revision or re-revision surgery where a polarcup shell was part of the hip construct.As such, no further information will be available.

Manufacturer Narrative

Section a2 and d10 were updated.Section h10: a total of 70 revision surgeries involving polarcup devices was reported by the uk national joint registry.104 complaints were opened accordingly.A review of the device history record (dhr), of the complaint history (chr), of the instruction for use (ifu), of the risk management file (rmr) and of past escalation (per) was performed.No relevant supporting clinical information was provided.Based on insufficient information, a thorough clinical assessment cannot be performed at this time.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined.Based on the chr and dhr evaluation performed there is no indication that any failure to meet specification contributed to the reported events.The reported failure modes are outlined in the device instruction for use lit no 12.23 03/21.The occurrence and severity of the reported issues are in line with the risk plans.The root cause of the reported events was attributed to known inherent risks of the devices.No corrective actions have been initiated.Internal complaint reference number: (b)(4) section h6 (clinical code and medical device problem code) was corrected.

• Brand Name: POLARCUP PE INSERT 49/28 NON-CEM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR 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: 15080192
• MDR Text Key: 296369790
• Report Number: 9613369-2022-00369
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 07611996096460
• UDI-Public: 07611996096460
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K070278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2017
• Device Model Number: 75017221
• Device Catalogue Number: 75017221
• Device Lot Number: B0911845
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/12/2010
• 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
• Treatment: 75017197/A0909303:POLARCUP SHELL 49 CEMENTED
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female