MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT DUOFIX TAP SZ5 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-02-110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	05/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Initial reporter occupation: lawyer investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.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
Asr litigation record received.Patient alleges that the acetabular cup eventually detached, disconnected, created metallic debris, and/or loosened from patient's acetabulum, grinding, and clicking for several months, caused patient's severe pain, and inhibited ability to walk.After review of medical record, patient was revised to address metalosis.Patient had elevated metal ion.Revision notes stated that there is significant inflammation of the capsule.There was some erosion of the bone on the inferior aspect of the acetabulum.There was trunnionosis from the cobalt chrome head against the trunnion and there was significant salt formation of the neck.Doi:(b)(6) 2008 - dor: (b)(6) 2020.(left hip).

• Brand Name: SUMMIT DUOFIX TAP SZ5 STD OFF
• 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: 11872642
• Report Number: 1818910-2021-11034
• Device Sequence Number: 3179151
• Product Code: LPH
• UDI-Device Identifier: 10603295059462
• UDI-Public: 10603295059462
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K011489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2020

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: Health Professional
• Device Model Number: 1570-02-110
• Device Catalogue Number: 157002110
• Device Lot Number: CA4LD1000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 05/24/2021
• 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: ASR ACETABULAR CUPS 58; ASR ACETABULAR CUPS 58; ASR UNI FEMORAL IMPL SIZE 51; SUMMIT DUOFIX TAP SZ5 STD OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR