MAUDE Adverse Event Report: DEPUY INT'L LTD. 8010379 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); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Pocket Erosion (2013); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/12/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Left tha performed in 2008 due to osteoarthritis.Asr implants and depuy summit stem were used.Revision was completed secondary to pain and metalosis.Operative notes stated that there was a slight increase in iron levels.Mri did not show evidence of pseudotumor.Significant inflammation of the capsule and erosion of the bony inferior aspect of the acetabulum was observed.Patient also experienced significant trunnionosis from the cobalt chrome head.Doi: (b)(6) 2008, dor: (b)(6) 2020, left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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 which has not been investigated or verified 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.
Event or Problem Description
Additional information was received indicating that this is an actively litigated asr case.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Mfr#: 1818910-2022-00248 is being retracted since it was found to be a duplicate of mrf#: 1818910-2021-11034.Mfr#: 1818910-2021-11034 will be kept for investigation purposes.

• Brand Name: SUMMIT DUOFIX TAP SZ5 STD OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13172668
• Report Number: 1818910-2022-00248
• Device Sequence Number: 11917251
• Product Code: LPH
• UDI-Device Identifier: 10603295059462
• UDI-Public: 10603295059462
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/05/2022

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 01/06/2022; 02/14/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 01/20/2022; 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ADAPTER SLEEVES 12/14 +2.; ASR ACETABULAR CUPS 58.; ASR UNI FEMORAL IMPL SIZE 51.
• Outcome Attributed to Adverse Event: Required Intervention; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male