MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. EP-FIT PLUS SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number UNKN1101002

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

Patient Problem Muscle Weakness (1967)

Event Date 01/18/2021

Event Type  Injury  

Event Description

On the literature article named "ceramic-on-ceramic vs ceramic-on-polyethylene, a comparative study with 10-year follow-up", it was reported that after a ep-fit plus shell had been implanted on 2 patients, after a 10 year follow up, atrophy around the cup was found in delee and charnley zone 1 in 2 patients from the cope group.It was not reported if/how the adverse event was treated.

Manufacturer Narrative

The study of van loon et.Al.[1] reports a 10-year study regarding the wear of ceramic-on-ceramic (coc) and ceramic-on-polyethylene (cope) hip pairings.17 cope and 25 coc cases were available for a follow-up.As this is a literature complaint, the parts, used in treatment, were not returned for investigation.It is reported, that in two cases the patients suffered from an atrophy.The part and the batch number of this device are not known.Therefore, it is not possible to investigate whether the reported device met manufacturing specification upon release for distribution.A complaint history review was conducted.The reported failure mode is stated as a side effect in the ifu lit.No.12.23 ed.05/16.The severity and the failure mode are covered through our risk management.As no device was received for investigation, a visual inspection could not be performed.No patient information nor any other medical documentation was provided, therefore, a thorough medical investigation could not be performed.Based on our investigations the failure mode and the relationship between the device and the reported event cannot be confirmed.Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event.To date, no further actions will be taken.Should additional information become available, this complaint will be reassessed.Smith and nephew will monitor the devices for further similar issues.[1]: van loon, j., hoornenborg, d., van der vis, h.M., sierevelt, i.N., opdam, k.T., kerkhoffs, g.M., & haverkamp, d.(2021).Ceramic-on-ceramic vs ceramic-on-polyethylene, a comparative study with 10-year follow-up.World journal of orthopedics, 12(1), 14¿23.Https://doi.Org/10.5312/wjo.V12.I1.14.

• Brand Name: UNKN. EP-FIT PLUS SHELL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11988906
• MDR Text Key: 255919230
• Report Number: 9613369-2021-00291
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 07/20/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN1101002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/27/2021
• Initial Date FDA Received: 06/13/2021
• Supplement Dates Manufacturer Received: 07/20/2021
• Supplement Dates FDA Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention