MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM COLLAR STD. TI/HA 5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Model Number 75018405

Device Problems Delivered as Unsterile Product (1421); Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2022

Event Type  malfunction  

Event Description

It was reported that, a polarstem collar std.Ti/ha 5 was receipt and it was noticed that the outer packaging was intact but inside was not sealed and product was damaged.As this was notice in a field inspection, no patient was involved.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H11: corrected information in h6 (medical device problem code).Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that, even though the product had a packaging problem, the sterile barrier was actually never compromised, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.

• Brand Name: POLARSTEM COLLAR STD. TI/HA 5
• 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: 15726583
• MDR Text Key: 303407749
• Report Number: 9613369-2022-00588
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 07611996103427
• UDI-Public: 07611996103427
• Combination Product (y/n): N
• PMA/PMN Number: K143739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 75018405
• Device Catalogue Number: 75018405
• Device Lot Number: C2201527
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 11/25/2022
• Supplement Dates FDA Received: 11/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1