MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX54OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Model Number 1218-87-354

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyst(s) (1800); Foreign Body Reaction (1868); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Necrosis (1971); Sepsis (2067); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 12/16/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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

Clinical notification received for revision due to infection.Date of implant: (b)(6) 2006, date of revision: (b)(6) 2022, (right hip).Treatment: revision; head, liner and shell were revised.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not received for examination.Based on the visual analysis of the provided photographic evidence for device, it cannot be determinate a depuy's device failure or malfunction which could contribute to reported event.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may 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.

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 Description

On (b)(6) 2006, patient received an uncemented right metal-on-metal total hip replacement with s-rom femur and pinnacle cup mom to address osteoarthritis.There were no reported complications.On (b)(6) 2022, patient had both the right and the left total hips revised to address hematogenous sepsis, fluid collections in both hips, acute pain and synovitis of the left hip, and chronic adverse reaction to metal debris of the right hip.A total of 400 ml fluid was drained from right hip and appeared grossly infected, as well as significant evidence of adverse reaction to metal debris, including complete destruction of the abductors and posterior capsule tissues, with only necrotic tissue remaining.There were multiple pockets of pus, even down into the thigh.The greater trochanter showed some avascular damage, and the posterior wall of the acetabulum was bony deficient, allowing the well-fixed cup to have migrated neutral to slightly retroverted in position.There was mild trunnionosis of the head and stem upon head removal.The s-rom stem was well-fixed; an attempt was made to remove/revise just the stem while leaving the s-rom proximal sleeve, but the interface could not be disrupted, so both components were left in place.The acetabular cup was removed due to concerns for dislocation, and a very large cup was placed to address the cup position and stability, with polyethylene liner and new metal head.Hip was well irrigated and debrided for treatment of the infection.The patient was significantly hypotensive at this point because of the sepsis, so following closure of the right hip, arterial and central lines were placed and hemostasis restored by anesthesiologist.

• Brand Name: PINNACLE MTL INS NEUT36IDX54OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16205027
• MDR Text Key: 307688909
• Report Number: 1818910-2023-01502
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1218-87-354
• Device Catalogue Number: 121887354
• Device Lot Number: 2275343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 01/19/2023
• Supplement Dates Manufacturer Received: 01/27/2023; 03/07/2023
• Supplement Dates FDA Received: 02/07/2023; 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2020
• 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: APEX HOLE ELIM POSITIVE STOP; PINNACLE 100 ACET CUP 54MM; PINNACLE MTL INS NEUT36IDX54OD; S-ROM M HEAD 36MM +3; S-ROM*SLEEVE PRX ZTT, 18D-LRG; SROM STM STD 36+12L 13X18
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 94 KG
• Patient Ethnicity: Hispanic
• Patient Race: White