MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT BASIC CEMENTED SZ 4; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-06-100
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Compass case (b)(4) report: it was reported that a removal of a loose cemented femoral component and a subsequent conversion of a hemi hip arthroplasty to a total hip were done the loosening interface was at cement to implant.Doi: (b)(6) 2016.Dor: (b)(6) 2021.Affected side: left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SUMMIT BASIC CEMENTED SZ 4
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12432221
• Report Number: 1818910-2021-19354
• Device Sequence Number: 14279979
• Product Code: JDI
• UDI-Device Identifier: 10603295059776
• UDI-Public: 10603295059776
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K023453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2021

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
• Operator of Device: Health Professional
• Device Model Number: 1570-06-100
• Device Catalogue Number: 157006100
• Device Lot Number: D15082078
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 09/28/2021; 09/23/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 09/28/2021; 10/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CEMENTRALIZER 11.0; MODULAR CATHCART BALL 43MM OD; SUMMIT BASIC CEMENTED SZ 4; TAPERED SPACER ARTICUL/EZE +0; UNKNOWN CEMENT MANUFACTURER; CEMENTRALIZER 11.0; MODULAR CATHCART BALL 43MM OD; SUMMIT BASIC CEMENTED SZ 4; TAPERED SPACER ARTICUL/EZE +0
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 44