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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	06/04/2018
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 9613369-2020-00180
• Device Sequence Number: 11644796
• Product Code: LZO
• UDI-Device Identifier: 07611996118575
• UDI-Public: 07611996118575
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 75100466
• Device Catalogue Number: 75100466
• Device Lot Number: B1604977
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 10/30/2020; 10/30/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 11/01/2020; 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention