MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT DUOFIX TAP SZ7 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-12-135
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Tissue Damage (2104); Test Result (2695); No Code Available (3191)
Date of Event	06/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter 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.
Event or Problem Description
Asr litigation and medical records received.After review of medical records, the patient was revised for failed right tha with elevated metal ion and positive mars mri consistent with a pseudotumor with soft tissue pockets of fluid, and persistent pain.Operative notes reported that there was a copious amount of liquid in the hip joint.Frozen section was negative for infection.Some of the abductors were debrided.There was soft tissue necrosis diffusely around the hip.No labs reported for the alleges elevated metal ions.Doi: (b)(6) 2009.Dor: (b)(6) 2020; right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.
Event or Problem Description
After review of medical record, patient was revised to address metallosis.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.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 (mre) was not performed.

• Brand Name: SUMMIT DUOFIX TAP SZ7 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
• MDR Report Key: 10601242
• Report Number: 1818910-2020-21126
• Device Sequence Number: 3321710
• Product Code: LPH
• UDI-Device Identifier: 10603295060185
• UDI-Public: 10603295060185
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K011489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/16/2020

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 Expiration Date: 07/31/2019
• Device Model Number: 1570-12-135
• Device Catalogue Number: 157012135
• Device Lot Number: D15CS1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 11/09/2020; 06/29/2021; 07/29/2021
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 11/10/2020; 07/16/2021; 08/04/2021
• 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: ADAPTER SLEEVES 12/14 +2; ASR 300 SPIKED CUP SIZE 54; ASR UNI FEMORAL IMPL SIZE 47; ADAPTER SLEEVES 12/14 +2; ASR 300 SPIKED CUP SIZE 54; ASR UNI FEMORAL IMPL SIZE 47
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR