MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ5 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-11-110

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Ambulation Difficulties (2544); Joint Laxity (4526); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Pinnacle medical records received.After review of the medical records, clinical visit reported consistent mom disease , pain and limited adl, difficulty walking and muscle weakness after first revision of the left hip.Doi: (b)(6) 2020, dor: unrevised, affected side: left hip.

Manufacturer Narrative

Product complaint # (b)(4).E3 initial reporter occupation: lawyer.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.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.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pinnacle medical records received.After review of the medical records, clinical visit reported consistent mom disease , pain and limited adl, difficulty walking and muscle weakness after first revision of the left hip.On 07/14/2020 cobalt 6.7 mcg/l chromium 34.6 mcg/l on (b)(6)2021 left hip mri noted a large fluid collection along with tears of the left gluteus medius and minimus tendon insertions.On 02/12/2021 lab results: chromium 24.3 ug/l.On (b)(6)2022 radiographs of the left hip are reported to show the acetabular component is a little vertical in orientation.The patient noted that their hip feels unstable.It was noted that on (b)(6)2022 the patient¿s hip dislocated and they needed a closed reduction.On 05/02/2022 lab values noted cobalt was 3.1 and chromium plasma was 33.5 with no unit of measurement provided.On (b)(6)2022 the patient left total hip revision to address instability, pain, and abductor weakness left hip.Prior to surgery, the patient reported that they feel popping and had dislocated.During this procedure, the surgeon observed large joint effusion, metal debris as evidenced by black synovial tissue.The patient¿s abductor muscles were noted to significantly weakened with evidence of metal-on-metal debris.The acetabular cup, head, and liner were removed and depuy acetabular cup along with placement of dual mobility head, inner poly and ceramic head.(surgery found on page 617 of 1656).Doi: (b)(6)2020 ; dor: (b)(6)2022; left hip.

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.Corrected: h6 health effect - impact code.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : pinnacle medical records received.After review of the medical records, clinical visit reported consistent mom disease , pain and limited adl, difficulty walking and muscle weakness after first revision of the left hip.Doi: (b)(6) 2020 ; dor: unrevised; left hip.The product was not returned to depuy synthes, however photos were provided for review.(b)(4).All available x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was unconfirmed as the observed condition of the [summit por taper sz5 hi off] would not contribute to a device issue neither to the reported adverse event.  based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SUMMIT POR TAPER SZ5 HI OFF
• Type of Device: 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17208273
• MDR Text Key: 317913110
• Report Number: 1818910-2023-13088
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295060062
• UDI-Public: 10603295060062
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/27/2023

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
• Device Operator: Health Professional
• Device Model Number: 1570-11-110
• Device Catalogue Number: 157011110
• Device Lot Number: A1JEC1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2023
• Initial Date FDA Received: 06/27/2023
• Supplement Dates Manufacturer Received: 06/22/2023; 03/28/2024
• Supplement Dates FDA Received: 07/07/2023; 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ALTRX +4 NEUT 36IDX58OD; ARTICULEZE M HEAD 36MM +1.5; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE SECTOR II CUP 58MM
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White