MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT BASIC CEMENTED SZ 2; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-06-080
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/01/2021
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
The primary surgery was performed on (b)(6) 2014.It was reported that the patient felt pain at femur in 2021.The patient was revised due to subsidence and the inversion of the stem by x-rays.In the revision surgery, the surgeon removed the cup and the stem without any problem, but he had difficulty in removing cement and the cement restrictor which he managed to remove eventually.There was no delay in the revision surgery.No further information is available.Doi: (b)(6) 2014.Dor: (b)(6) 2021; unknown side.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: SUMMIT BASIC CEMENTED SZ 2
• 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: 11485985
• Report Number: 1818910-2021-05096
• Device Sequence Number: 14372235
• Product Code: JDI
• UDI-Device Identifier: 10603295059752
• UDI-Public: 10603295059752
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K023453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2021

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: 1570-06-080
• Device Catalogue Number: 157006080
• Device Lot Number: 288126
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 05/11/2021
• 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: ARTICUL/EZE BALL 28 +1.5 GR; CEMENT RESTRICTOR SIZE 4; J-FX BIPOL SHELL&28MMLINR/47MM; STREAMLINE SZ 10.0 PK/10; SUMMIT BASIC CEMENTED SZ 2; ARTICUL/EZE BALL 28 +1.5 GR; CEMENT RESTRICTOR SIZE 4; J-FX BIPOL SHELL&28MMLINR/47MM; STREAMLINE SZ 10.0 PK/10; SUMMIT BASIC CEMENTED SZ 2
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR