MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX52OD; HIP METAL ACETABULAR LINERS

Catalog Number 121887352

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

Patient Problems Foreign Body Reaction (1868); Hematoma (1884); Pain (1994)

Event Date 08/29/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint (b)(4).H10 additional narrative: d4, d6: the information provided regarding the expiration date and implantation date are identified to be conflicting.Continued follow-up is being conducted and any additional information received will be reported.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.

Event Description

It was reported that on an unknown date in (b)(6) 2017, the primary surgery was performed via tha with the implants in question.After the surgery, the patient complained of pain because the hematoma accumulated from around the prosthesis to distal to the prosthesis.On (b)(6) 2023, the revision surgery was performed to replace the liner and the head due to the suspected armd caused by mom.The surgeon commented that the hematoma is widely formed and the lateral antrum is dissolving, which may be caused by armd.He also considers that the cup has an outward opening angle of about 50 degrees, which may be causing armd.Patient¿s medical history: tha after external osteotomy no further information is available.Doi: (b)(6) 2017; doe: (b)(6) 2023; affected side: unknown.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : it was reported that on an unknown date in (b)(6) 2017, the primary surgery was performed via tha with the implants in question.After the surgery, the patient complained of pain because the hematoma accumulated from around the prosthesis to distal to the prosthesis.On (b)(6) 2023, the revision surgery was performed to replace the liner and the head due to the suspected armd caused by mom.The surgeon commented that the hematoma is widely formed and the lateral antrum is dissolving, which may be caused by armd.He also considers that the cup has an outward opening angle of about 50 degrees, which may be causing armd.Patient¿s medical history: tha after external osteotomy.The product was not returned to depuy synthes, however photos were provided for review.(b)(4).The photo/x-ray investigation revealed that pinnacle mtl ins neut36idx52od presented nothing indicative of a device nonconformance or a relation with the reported event.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 pinnacle mtl ins neut36idx52od would not contribute to a device issue.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 : a manufacturing record evaluation was performed for the finished device [121887352 /2437462] number, and no non-conformances / manufacturing irregularities were identified.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : it was reported that on an unknown date in (b)(6) 2017, the primary surgery was performed via tha with the implants in question.After the surgery, the patient complained of pain because the hematoma accumulated from around the prosthesis to distal to the prosthesis.On (b)(6) 2023, the revision surgery was performed to replace the liner and the head due to the suspected armd caused by mom.The surgeon commented that the hematoma is widely formed and the lateral antrum is dissolving, which may be caused by armd.He also considers that the cup has an outward opening angle of about 50 degrees, which may be causing armd.Patient¿s medical history: tha after external osteotomy no further information is available.The device associated with this report was returned to depuy synthes for evaluation.Visual inspection of the returned device found nothing indicative of a device nonconformance.The adverse symptoms alleged and product code reported is associated with the depuy metal on metal articulation.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was unconfirmed as the observed condition of the pinnacle mtl ins neut36idx52od would not contribute 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 reported 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 complaint database search and/or device manufacturing (dhr) reviews will not be performed due to the reported adverse events are known inherent risks of metal on metal devices.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : it was reported that on an unknown date in (b)(6) 2017, the primary surgery was performed via tha with the implants in question.After the surgery, the patient complained of pain because the hematoma accumulated from around the prosthesis to distal to the prosthesis.On (b)(6) 2023, the revision surgery was performed to replace the liner and the head due to the suspected armd caused by mom.The surgeon commented that the hematoma is widely formed and the lateral antrum is dissolving, which may be caused by armd.He also considers that the cup has an outward opening angle of about 50 degrees, which may be causing armd.Patient¿s medical history: tha after external osteotomy.The product was not returned to depuy synthes, however photos were provided for review.(b)(4).The photo/x-ray investigation revealed that pinnacle mtl ins neut36idx52od presented nothing indicative of a device nonconformance or a relation with the reported event.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 pinnacle mtl ins neut36idx52od would not contribute to a device issue.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 : a manufacturing record evaluation was performed for the finished device [121887352 /2437462] number, and no non-conformances / manufacturing irregularities were identified.

• Brand Name: PINNACLE MTL INS NEUT36IDX52OD
• Type of Device: HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17807159
• MDR Text Key: 324129316
• Report Number: 1818910-2023-18764
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K003523
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/25/2023

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 Expiration Date: 08/08/2012
• Device Catalogue Number: 121887352
• Device Lot Number: 2437462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/25/2023
• Supplement Dates Manufacturer Received: 09/28/2023; 01/12/2024; 02/07/2024; 03/12/2024
• Supplement Dates FDA Received: 09/29/2023; 01/16/2024; 02/09/2024; 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 9/10 ULTAMET 36MM HEADS +0; UNKNOWN HIP ACETABULAR CUP
• Patient Outcome(s): Required Intervention
• Patient Sex: Female