MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM COLLAR STD. TI/HA 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Model Number 75018403

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Purulent Discharge (1812)

Event Date 10/29/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, two weeks after a revision thr surgery had been performed, the patient experienced pus from the wound.The infection was solved via two-stage revision surgery, whose first leg took place on (b)(6) 2021.Implants were removed without issue and a cement spacer was implanted.Current health status of patient is unknown.

Manufacturer Narrative

Section: h3, h6: it was reported that, two weeks after a revision thr surgery had been performed, the patient experienced pus from the wound.The infection was solved via revision surgery.A polarstem collar std.Ti/ha 3 was removed without issues.The device intended for use in treatment was not returned for investigation.An evaluation of the complained device could therefore not be conducted and the reported failure mode could not independently be confirmed.A medical investigation was performed.With the limited information provided the root cause of the reported infection cannot be confirmed; however, the patient¿s history of long-term immunosuppression cannot be ruled out as a contributing factor.The infection is highly likely of an exogenous nature and there is no evidence that our product contributed to the infection.The patient impact beyond the revision and expected transient post-op convalescence period cannot be determined.A review of the complaint history revealed no additional complaint for the batch in question.A review of the batch record revealed no deviations from the standard manufacturing process that could have contributed to the reported issue.The ifu (lit.No.12.23 ed 03/21) lists infection as a known possible side effect resulting from a hip arthroplasty.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Based on the performed investigations, the reported failure mode could not be confirmed.A relationship between the reported event and the device cannot be confirmed.There is no indication that the reported device failed to meet 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.The root cause for the reported infection stays undetermined.The need for corrective action is not indicated.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: POLARSTEM COLLAR STD. TI/HA 3
• 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: 12829777
• MDR Text Key: 280895739
• Report Number: 9613369-2021-00413
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 07611996103403
• UDI-Public: 07611996103403
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K143739
• 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
• Report Date: 12/22/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 75018403
• Device Catalogue Number: 75018403
• Device Lot Number: B2003900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2021
• Initial Date FDA Received: 11/17/2021
• Supplement Dates Manufacturer Received: 12/21/2021
• Supplement Dates FDA Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 61 YR
• Patient Sex: Female