MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS INTEGR MIA STEM WITH TI/HA 5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED

Model Number	75000178
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, foreign body material on stem was found when opening the product.There was 3 mins delay reported.Substitute product was not prepared.
Additional Manufacturer Narrative
It was reported that during surgery, foreign body material on a sl-plus integr mia stem was found when opening the product.The stem intended for use in treatment was not returned for investigation.Nevertheless the foreign body was sent back and was examined.It is of green colour and of a size of about 3.5mm x 0.6mm.A microscopic and elemental analysis was performed.In stereomicroscopic view, on the foreign body material itself many smaller particles are visible, some of darker and some of brighter colour.From the aspects and elements found on the foreign body material, this might be a polymeric material, contaminated with various kind of small particles.By reviewing the current version (81080947-b) of our ifu for hip implants 12.23 ed.05/16, it was noticed that it's not explicitly mentioned that if a foreign body is discovered, the respective implant should not be implanted anymore.A new ifu version has already been submitted.The risk of contamination is in both risk files (s+n's and the packaging supplier's) mentioned and considered to be low.The corresponding batch records did not show any discrepancy which could relate to the reported failure.A complaint review was already performed with the first investigation, no other complaint was found for the reported batch number.The returned device will be retained.S+n will monitor this device for similar issues.

• Brand Name: SL-PLUS INTEGR MIA STEM WITH TI/HA 5
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 9536977
• Report Number: 9613369-2019-00109
• Device Sequence Number: 2696903
• Product Code: LZO
• UDI-Device Identifier: 07611996092806
• UDI-Public: 07611996092806
• Combination Product (Y/N): N
• PMA/510(K) Number: K122296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/24/2026
• Device Model Number: 75000178
• Device Catalogue Number: 75000178
• Device Lot Number: C1913361
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 12/31/2019
• Supplement Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 30