MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 58MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-22-058

Device Problems Use of Device Problem (1670); 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); Muscle/Tendon Damage (4532); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 06/13/2023

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; 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.

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.The x-ray investigation revealed the pinnacle sector ii cup 58mm is not as it ideal position described by the surgical technique.The provided evidence indicates that the intervention angle deviates from the stipulated surgical technique, where the cup appears to be positioned at angles greater than 45 degrees of abduction, additionally an increase in the degrees of anteversion is noted, which should ideally fall within the range of 15 to 30 degrees, as specified in the surgical technique.In comparison to the angles proposed by the surgical technique, page 18.This evidence, combined with the potential movements generated and the force exerted by the patient's weight, could lead to the reported allegation.Therefore, it is recommended to adhere to the surgical technique.One observation is that the femoral head appears not to be in the most appropriate position due to the implantation angle of the cup.A root cause cannot be definitively established.Please refer to pinnacle hip solutions surgical technique dsus/jrc/0414/0026 rev.3.The observed condition of the pinnacle sector ii cup 58mm might have contributed to the reported adverse events like joint instability and walking difficulty.However bases on the investigation a definitive root cause cannot be determined due to multiple factors being involved and a the surgical process being suspected to be one of them.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 confirmed.As the observed condition of the [pinnacle sector ii cup 58mm] would contribute to the complained device issue and adverse events.  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.Device history batch: null.Device history review: null.

• Brand Name: PINNACLE SECTOR II CUP 58MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• 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: 17280077
• MDR Text Key: 318648030
• Report Number: 1818910-2023-13744
• Device Sequence Number: 1
• Product Code: LPH
• 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
• Report Date: 07/07/2023

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: 1217-22-058
• Device Catalogue Number: 121722058
• Device Lot Number: AV1B21000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2023
• Initial Date FDA Received: 07/07/2023
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2006
• 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; SUMMIT POR TAPER SZ5 HI OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White