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

Model Number 75100466

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

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 06/04/2018

Event Type  Injury  

Event Description

It was reported that two-stages revision surgery was performed two years after primary procedure due to loosening and infection with placement of antibiotic spacers.

Manufacturer Narrative

It was reported that two-stages revision surgery was performed two years after primary procedure due to loosening and infection with placement of antibiotic spacers.The claimed article is a polarstem stem std ti/ha 3 non-cem, which intent use is in treatment.The part was not returned for investigation.Furthermore, no clinical documentation was made available.Therefore a thorough product or clinical investigation could not be performed.Due to the dhr review there's no indication that the product failed in any way.No deviation was found in the corresponding batch record and sterilization certificate.For the specific batch no other complaint can be found.Therefore, a product failure will not be assumed.Infection is a possible side effect of a total hip endoprosthesis, which is mentioned in our current instruction for use for hip implants 12.23 ed.05/16 and has several possible root causes.In this case the root cause can not be determined and further actions seem not necessary without the adequate medical documentation.S+n will monitor this device for similar issues.

Manufacturer Narrative

It was reported that two-stages revision surgery was performed two years after primary procedure due to loosening and infection with placement of antibiotic spacers.The claimed article is a polarstem stem std ti/ha 3 non-cem, which intent use is in treatment.The part was not returned for investigation.Furthermore, no clinical documentation was made available.Therefore a thorough product or clinical investigation could not be performed.Due to the dhr review there's no indication that the product failed in any way.No deviation was found in the corresponding batch record and sterilization certificate.For the specific batch no other complaint can be found.Therefore, a product failure will not be assumed.Infection is a possible side effect of a total hip endoprosthesis, which is mentioned in our current instruction for use for hip implants (b)(6) 23 ed.(b)(6) 16, and has several possible root causes.In this case the root cause can not be determined and further actions seem not necessary without the adequate medical documentation.S+n will monitor this device for similar issues.

• Brand Name: POLARSTEM STEM STD TI/HA 3 NON-CEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10551951
• MDR Text Key: 207505182
• Report Number: 9613369-2020-00180
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07611996118575
• UDI-Public: 07611996118575
• Combination Product (y/n): N
• PMA/PMN Number: K130728
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2020

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
• Device Operator: Health Professional
• Device Model Number: 75100466
• Device Catalogue Number: 75100466
• Device Lot Number: B1604977
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 10/30/2020; 10/30/2020
• Supplement Dates FDA Received: 11/01/2020; 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention