MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX LIP LNR 32IDX52OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	122132252
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Insufficient Information (4580)
Date of Event	05/22/2024
Type of Reportable Event	Death
Event or Problem Description
Surgeon had a total hip that he planned to use corail pinnacle for.Templated before the case started.Followed surgical technique and dislocated femur, resected femoral head and moved onto acetabulum.Reamed using a small reamer, and progressed in size using equal increments of 2.Got to size 52 and trialed.Definitive 52 cup was opened.Drilled and measured for screw placement, using appropriate drill bit, guide and depth gauge.2 definitive screws opened (20mm and 15mm).Opened liner 32mm by 52mm lipped and inserted and impacted as per technique.Moved back to femur and reamed using t-handle starting with size 8 and going up in increments of.Broached starting at size 8, and going up in increments of 1 till size 11 broach felt stable doing appropriate checks trialed std 135 neck and 32 head +5.Tried to remove broach but got stuck distally, removed broach after changing instruments to gain better leverage.Broach with a 12 and had better stability.Opened a definitive standard collar 12 stem and 32 +5 head.Reduced patient, checked leg length.Surgeon was happy.No concerns or issues were noted.Patient died a few hours after surgery, after an attempt to move them to hospital to stabilize them.There were no adverse events relating to product while in theatre or after- complications took place in post op and details of those complications are sensitive and known by medical staff and surgeon.
Additional Manufacturer Narrative
Product complaint # (b)(4).There is limited information regarding the patient's death at this time.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that 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 or Problem Description
1.The patient died as a result of surgery.2.The patient died as a result of elective surgery and the procedure itself, not the products used.3.There are no additional notes on this, as it has been referred to the coroner's office.It was suspected blood loss and complications were associated with this.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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 records evaluation (mre) was not perform.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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.Corrected: d4 (primary udi #).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.According to the information received, ¿total hip done on [date].Surgeon had a total hip that he planned to use corail pinnacle for.Templated before the case started.Followed surgical technique and dislocated femur, resected femoral head and moved onto acetabulum.Reamed using a small reamer, and progressed in size using equal increments of 2.Got to size 52 and trialed.Definitive 52 cup was opened.Drilled and measured for screw placement, using appropriate drill bit, guide and depth gauge.2 definitive screws opened (20mm and 15mm).Opened liner 32mm by 52mm lipped and inserted and impacted as per technique.Moved back to femur and reamed using t-handle starting with size 8 and going up in increments of broached starting at size 8, and going up in increments of 1 till size 11 broach felt stable doing appropriate checks trialed std 135 neck and 32 head +5.Tried to remove broach but got stuck distally, removed broach after changing instruments to gain better leverage.Broach with a 12 and had better stability.Opened a definitive standard collar 12 stem and 32 +5 head.Reduced patient, checked leg length.Surgeon was happy.Rep left case after surgeon started to suture the patient closed.No concerns or issues were noted.Patient died a few hours after surgery, after an attempt to move them to [hospital] to stabilize them.(unaware that this needed to be reported until today 31 may as instructed by management, as there were not adverse events relating to product while in theatre or after- complications took place in post op and details of those complications are sensitive and known by medical staff and surgeon.¿ product description:- altrx lip lnr 32idx52od product code:- 122132252 lot no:- m40c98 quantity of manufactured:- (b)(4) date of manufacturing:- 16-aug-2023 expiry date:- 31-jul-2028 as part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: product description:- altrx lip lnr 32idx52od, product code:- 122132252, lot no:- m40c98, quantity of manufactured: (b)(4), date of manufacturing:- 16-aug-2023, expiry date:- 31-jul-2028.Device history review: a manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities were identified.H11 additional narrative: corrected: g1 (manufacturer site country code), h8.

• Brand Name: ALTRX LIP LNR 32IDX52OD
• 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 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 19478407
• Report Number: 1818910-2024-12404
• Device Sequence Number: 15221934
• Product Code: LPH
• UDI-Device Identifier: 10603295016199
• UDI-Public: (01)10603295016199(17)280731(10)M40C98
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K072963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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,Followup,Followup
• Report Date (Section B): 06/06/2024

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 Catalogue Number: 122132252
• Device Lot Number: M40C98
• 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: Not provided
• Supplement Date Received by Manufacturer: 06/07/2024; 07/22/2024; 04/16/2025
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 06/14/2024; 07/23/2024; 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2023
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORAIL AMT COLLAR SIZE 12; DELTA CER HEAD 12/14 32MM +5; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN SECTOR W/GRIPTION 52MM
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Sex: Unknown