MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT DUOFIX TAP SZ6 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-12-120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Numbness (2415); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Asr medical record received.After review of medical record, patient was revised due to local adverse tissue reaction secondary to metallosis.Patient had elevated metal ion levels and experienced pain.Revision notes stated that a dark tea-colored thin synovial fluid was encountered.There was small amount of trunnionosis at the base of the trunnion.The acetabular component was noted to have a step-off on the inner diameter resulting in a very sharp edge.Cup was removed with a very minimal bone loss.Bone scan of the bilateral hips done (b)(6) 2021 stated increased periprosthetic tracer uptake greatest along the proximal femoral component at the greater trochanter to lesser trochanter, there is possible hardware loosening.Mri of left hip last (b)(6) 2021 stated that there is no fracture or definite loosening seen.There maybe periprosthetic effusion noted.Laboratory result last (b)(6) 2021 for chromium was 3ng/ml and cobalt was 6.9ng/ml.Doi: (b)(6) 2009.Dor: (b)(6) 2021.(left hip).
Additional Manufacturer Narrative
Product complaint #: (b)(4).Initial reporter occupation: lawyer.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).Investigation summary : the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.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 manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mrae) was not performed.
Event or Problem Description
Additional information received indicated that the patient experienced severe pain, discomfort, increased metal levels in blood including cobalt & chromium, permanent injuries, emotional distress, disability and disfigurement that led to patient's revision on (b)(6) 2021.
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.
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.
Event or Problem Description
After review of the medical records and pfs, patient stated the he was certain as to when the symptoms began right after the implantation of the device.The patient experienced severe pain to his left hip and numbness of his feet, toes and both hands.

• Brand Name: SUMMIT DUOFIX TAP SZ6 HI OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13453589
• Report Number: 1818910-2022-02304
• Device Sequence Number: 11975456
• Product Code: LPH
• UDI-Device Identifier: 10603295060178
• UDI-Public: 10603295060178
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K193398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/04/2022

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: 1570-12-120
• Device Catalogue Number: 157012120
• Device Lot Number: CT6EB1000
• 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: 01/25/2022
• Supplement Date Received by Manufacturer: 03/14/2022; 12/23/2022; 02/27/2023
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 03/15/2022; 12/28/2022; 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2008
• 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 +8; ASR 300 SPIKED CUP SIZE 54; ASR UNI FEMORAL IMPL SIZE 47
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male