MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR NEUT 28IDX50OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	121928050
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary total hip implanted with depuy synthes components (corail stem, pinnacle shell).The patient informed family members the she was experiencing hip pain and revision total hip surgery was performed on the patient.When the surgeon exposed the joint, it was discovered that the articuleze head (28 +5), was articulating on the interior of the acetabular shell.There was a large hole worn in the shell (50 sector gription), and the marathon polyethylene liner (28/50 neutral), was dissociated from the acetabular shell.The shell, liner and head were then explanted, the wound was washed out thoroughly, acetabulum was reamed up to 53mm, and a 54 multihole gription shell was implanted, followed by a 54/47 pinnacle dual mobility metal liner, a 47/28 pinnacle bimentum altrx head, and a 28 +1.5mm cocr articuleze femoral head.The hip was then reduced, and the wound closed up.No additional information is available.
Additional Manufacturer Narrative
Product complaint #: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the patient had a primary total hip implanted in (removed) with depuy synthes components (corail stem, pinnacle shell).In (removed), the patient informed family members the she was experiencing hip pain.Revision total hip surgery was performed on the patient in (removed).When the surgeon exposed the joint, it was discovered that the articuleze head (28 +5), was articulating on the interior of the acetabular shell.There was a large hole worn in the shell (50 sector gription) , and the marathon polyethylene liner (28/50 neutral), was dissociated from the acetabular shell.The shell, liner and head were then explanted, the wound was washed out thoroughly, acetabulum was reamer up to 53mm, and a 54 multihole gription shell was implanted, followed by a 54/47 pinnacle dual mobility metal liner, a 47/28 pinnacle bimentum altrx head, and a 28 +1.5mm cocr articuleze femoral head.The hip was then reduced, and the wound closed up.The product was not returned to depuy synthes, however photos were provided for review.See attachment [img_5337.Jpeg, img_5338.Jpeg].The photo investigation revealed that several pinn mar neut 28idx50od anti rotational devices (ard tabs) were sheared off.Additionally wear and deformation were observed at the rim of the liner.Based on the observations made the implant, it is reasonable to conclude that a disassociation event occurred between the acetabular cup and liner.With the information provided is not possible to determine a potential cause at this moment, however in support of the evaluation performed, the observed damage of the pinn mar neut 28idx50od may have been caused by exposure to irregularities in the weight loading of the device and moments generated.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the pinn mar neut 28idx50od would contribute to the complained device issue.Based on the investigation findings and 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: a manufacturing record evaluation was performed for the finished device fc6kc1/121928050, and no non-conformances / manufacturing irregularities related to the malfunction were identified.

• Brand Name: PINN MAR NEUT 28IDX50OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18028862
• Report Number: 1818910-2023-21766
• Device Sequence Number: 12280460
• Product Code: LPH
• UDI-Device Identifier: 10603295013297
• UDI-Public: 10603295013297
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/18/2016
• Device Catalogue Number: 121928050
• Device Lot Number: FC6KC1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 11/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2011
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PINN SECTOR W/GRIPTION 50MM.; UNKNOWN HIP FEMORAL HEAD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown