MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS MIA STEM 01 NON-CEM; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Model Number	75001937
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery of sl-plus mia (non ha) due to loosening.
Additional Manufacturer Narrative
It was reported that sl mia stem and a biolox forte ball head were implanted and revised due to loosening of the sl mia stem.Both the stem and the ball head were received for investigation.A visual analysis was conducted.It can be confirmed that both devices were implanted.The stem showed some bone residuals as well as significant signs of wear.There are several scratches on the neck and the cone, which are probably due to the revision surgery.The ball head also shows signs of use with one larger breakout on the polished surface.A material analysis confirmed secondary metal transfer as a result of contact with metal part or surgical instruments during the revision.Also expected primary metal transfer can be found.The ball head shows an area of increased wear, which could have been caused by edge loading, mirco-separation or subluxation.The material analysis did not reveal any deviations from specifications.The density of the matieral is complying with the delivery specification.Also the production documentation review of both devices did not reveal any deviation from standard procedures.No medical documentation with further information were received, therefore a thorough medical assessment could not be performed.For this device combination, one complaint with the same failure mode was reported, however that one was not product related.The combination of the ball head and the stem is approved by smith and nephew.Based on the available information the root cause for the loosening of the stem cannot be determined.At this time, no further action are deemed necessary.Smith and nephew will monitor both devices for further similar issues.The stem and the ball head will be archived.
Additional Manufacturer Narrative
It was reported that sl mia stem and a biolox forte ball head were implanted and revised due to loosening of the sl mia stem.Both the stem and the ball head, used in treatment, were received for investigation.A visual analysis was conducted.It can be confirmed that both devices were implanted.The stem showed some bone residuals as well as significant signs of wear.There are several scratches on the neck and the cone, which are probably due to the revision surgery.The ball head also shows signs of use with one larger breakout on the polished surface.A material analysis confirmed secondary metal transfer as a result of contact with metal part or surgical instruments during the revision.Also expected primary metal transfer can be found.The ball head shows an area of increased wear, which could have been caused by edge loading, mircoseparation or subluxation.The material analysis did not reveal any deviations from specifications.The density of the material is complying with the delivery specification.The goldberg score was assessed, it results in a 3 for the sl stem, as more than 30% of the surface area show discolorations.The score for the ball head is a 2, meaning that less than 30% show discoloration.The assessment of the goldberg score is a visual method and subjective.The production documentation review of both devices did not reveal any deviation from standard procedures.No medical documentation with further information were received, therefore a thorough medical assessment could not be performed.For this device combination, one complaint with the same failure mode was reported, however it was not product related.The combination of the ball head and the stem is approved by smith and nephew.The risk of loosening is covered through our risk management files.According to ifu lit no.12.23, ed.05/16, loosening is a possible side effect.Based on the available information the root cause for the loosening of the stem cannot be determined.At this time, no further action are deemed necessary.Smith and nephew will monitor both devices for further similar issues.The stem and the ball head will be returned to the customer.

• Brand Name: SL-PLUS MIA STEM 01 NON-CEM
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; baar 06340 ; SZ 06340
• MDR Report Key: 9167874
• Report Number: 9613369-2019-00075
• Device Sequence Number: 2592413
• Product Code: LZO
• UDI-Device Identifier: 07611996078855
• UDI-Public: 07611996078855
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2020

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 Expiration Date: 03/30/2015
• Device Model Number: 75001937
• Device Catalogue Number: 75001937
• Device Lot Number: B0800308
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 09/12/2019; 09/12/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 02/25/2020; 08/06/2020
• 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