MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT DUOFIX TAP SZ4 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-02-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
21.12.05 primary hip operation.Implants used: 58mm 100 pinnacle cup, hole eliminator, metal insert, size 4 summit stem, 36 + 8.5 metal on metal head.Pt presented with groin pain and elevated metal ion levels.Pt revised today ¿ head and liner and hole eliminator removed.Same replaced with poly lipped liner for 58mm cup, hole eliminator and a ts ceramic 36+8.5 head.Xrays to follow and picture of the liner removed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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 : no anomalies or deviations were found during the review.

• Brand Name: SUMMIT DUOFIX TAP SZ4 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: 12468066
• Report Number: 1818910-2021-20035
• Device Sequence Number: 3874105
• Product Code: LPH
• UDI-Device Identifier: 10603295059455
• UDI-Public: 10603295059455
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K011489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1570-02-100
• Device Catalogue Number: 157002100
• Device Lot Number: ZS7EV1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 10/21/2021
• 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: APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +8.5; PINNACLE 100 HA ACET CUP 58MM; PINNACLE MTL INS NEUT36IDX58OD; SUMMIT DUOFIX TAP SZ4 STD OFF; APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +8.5; PINNACLE 100 HA ACET CUP 58MM; PINNACLE MTL INS NEUT36IDX58OD; SUMMIT DUOFIX TAP SZ4 STD OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 74