MAUDE Adverse Event Report: PLUS ORTHOPEDICS (SMITH AND NEPHEW) PLUS CERAMIC CERAMIC BALL HD 36 M; PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC/POLYMER CEMENTED, UNCEMENTED

Catalog Number	75007442
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	08/23/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient was complaining of pain.A revision surgery was performed due to infection.
Additional Manufacturer Narrative
With the additional information obtained, the manufacturer number of this report should be 9613369.
Event or Problem Description
It was reported that a revision surgery was performed due to inflammatory pseudotumor after ceramic-on-ceramic total hip.
Additional Manufacturer Narrative
Results of investigation: a complaint due to a revision of a ceramic ball head was reported.No device was returned for investigation.A review of the production documentation and of the complaint history showed no elements that may have contributed to an infection.The found inflammatory pseudotumor shows similarities with histopathological findings of adverse local tissue reactions.It was suggested that this is related to the ceramic-ceramic pairing.The mentioned publication reports on an inflammatory pseudotumor/adverse local tissue reaction in the absence of cobalt-chromium modular necks as well as on findings similar to reactions known from metal related issues.As the explanted cobalt-chromium femoral neck-stem combination has a known history of metal related failures and the material analysis showed corrosion on the neck taper, it is more likely that the reported findings relate to the modular neck.This was judged in the absence of the ceramic pairing for investigation.Based on the available information, no thorough investigation can be performed and the root cause of the a revision of a ceramic ball head remains undetermined.If the additional information or the explanted ball head become available this investigation will be reopened.No further actions have been initiated.

• Brand Name: PLUS CERAMIC CERAMIC BALL HD 36 M
• Common Device Name: PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC/POLYMER CEMENTED, UNCEMENTED
• Manufacturer (Section D): PLUS ORTHOPEDICS (SMITH AND NEPHEW); friesenweg 4; memphis, tennessee; hamburg 22763 ; GM 22763
• MDR Report Key: 7915274
• Report Number: 1020279-2018-01913
• Device Sequence Number: 19390398
• Product Code: LZO
• UDI-Device Identifier: 03596010597618
• UDI-Public: 03596010597618
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K070928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2019

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: No Information
• Device Expiration Date: 01/08/2021
• Device Catalogue Number: 75007442
• Device Lot Number: C1133601
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/03/2018
• Supplement Date Received by Manufacturer: 09/03/2018; 09/03/2018
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 11/16/2018; 02/19/2019
• 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
• Patient Weight: 84