MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR CUP PINNACLE

Catalog Number UNK HIP ACETABULAR CUP PINNACL

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Autoimmune Disorder (1732); Fatigue (1849); Hematoma (1884); Muscular Rigidity (1968); Pain (1994); Distress (2329); Joint Dislocation (2374); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/02/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.Component code: (b)(4).Health effect - clinical code: (b)(4).Investigation summary no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Asr litigation received.Litigation alleges right hip pain, suffering and mental anquish.It was also indicate that patient was revised due to excessive levels of chromium and cobalt.Doi: sep 1, 2003.Dor: nov 2, 2018.Right hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary - no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot - device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.

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

Medical records received indicate that on (b)(6) 2018, the patient was revised due to closed dislocation and mechanical complications.On (b)(6) 2018, a surgical pathologist reported a hardware fracture.No specific device mentioned was fractured.

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.Added: a4, a5, a6, b5, b6, b7, h6 health effect - clinical code.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical record received.In addition to what was previously reported in the medical records.After review of the records clinical visit reported joint pain, stiffness, fatigue, dry mouth, diffuse myalgia, polyarthralgia and emotional distress.Radiology reported, mild multi level spondylosis, posterior fusion hardware in site l4-5 and l5-s1 disc space is narrowed.There is a minor anterior osteophyte formation.Here is sclerosis of the acetabular rim consistent with osteoarthritis.Patient had elevated metal ions.He had hematoma post procedure and significant drop of hematocrit.

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

Medical records received.(b)(6) 2018 the patient had a recent hip arthroplasty 2 weeks ago and presented to the er this morning with right hip dislocation.The patient was taken to the or for right hip revision.Pathology noted specimen labled 1221 36 060 which is altrx neut 36idx60od.The patient had a right hip revision, irrigation, and debridement to address dislocation.The head and liner were revised.The surgeon reported that there was soft tissue within the acetabulum.The soft tissue was removed.(b)(6) 2018 - (b)(4) revision for metal ions (1st event).(b)(6) 2018 - (b)(4) revision for dislocation (2nd event).(b)(6) 2018 - (b)(4) post op events (3rd event).

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.H10 additional narrative: added: b5 and h6 (clinical code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: b3 and d6b.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: according to the information received, asr litigation received.Litigation alleges right hip pain, suffering and mental anquish.It was also indicate that patient was revised due to excessive levels of chromium and cobalt.Doi: (b)(6) 2003; dor: (b)(6) 2018; right hip.The product was not returned to depuy synthes, however photos were provided for review.See attachment (b)(4).The x-ray investigation revealed nothing indicative of a device nonconformance.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the unk hip acetabular cup pinnacle 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: the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: according to the information received, asr litigation received.Litigation alleges right hip pain, suffering and mental anquish.It was also indicate that patient was revised due to excessive levels of chromium and cobalt.Doi: (b)(6) 2003.Dor: (b)(6) 2018.Right hip.The product was not returned to depuy synthes, however photos were provided for review.See attachment (b)(4)_x-ray_images-received (b)(6) 2023 and (b)(4) _x-ray_images-received (b)(6) 2023.The x-ray investigation revealed nothing indicative of a device nonconformance.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the unk hip acetabular cup pinnacle 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: the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

Event Description

X-ray images were provided on discs received from legal.Review of the x-rays found images taken on (b)(6) 2017 and (b)(6) 2017.Both sets of images showed a pinnacle metal liner and pinnacle cup with two pinnacle screws implanted.The product codes are unknown.Based on the x-ray review, there were no asr components involved at the time of the revision on (b)(6) 2018.Instead, the components most likely revised would have been: unk cup pinnacle, unk femoral head, and unk hip acetabular liner metal pinnacle.It was noted that the dislocation pertained to the implants listed in (b)(4) and have been reported in that pc.There was no mention of the metal on metal pinnacle implants dislocating.Update: changed ip-01266655 from unk hip femoral head metal asr to unk femoral head, ip-01266656 from unk hip femoral sleeve asr to unk hip acetabular liner metal pinnacle and ip-01266658 unk hip acetabular cup asr to unk hip acetabular cup pinnacle as per findings.

• Brand Name: UNK HIP ACETABULAR CUP PINNACLE
• Type of Device: HIP ACETABULAR CUP
• 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 LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12661051
• MDR Text Key: 277266392
• Report Number: 1818910-2021-22971
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/05/2021
• 2 Devices were Involved in the Event: 1 2

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 Catalogue Number: UNK HIP ACETABULAR CUP PINNACL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/05/2021
• Initial Date FDA Received: 10/19/2021
• Supplement Dates Manufacturer Received: 06/26/2023; 07/03/2023; 11/10/2023; 11/28/2023; 12/15/2023; 02/07/2024; 02/14/2024
• Supplement Dates FDA Received: 06/30/2023; 07/03/2023; 11/14/2023; 12/12/2023; 01/11/2024; 02/14/2024; 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: UNK HIP ACETABULAR CUP ASR.; UNK HIP FEMORAL HEAD METAL ASR.; UNK HIP FEMORAL SLEEVE ASR.; UNKNOWN HIP FEMORAL STEM.; UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL HEAD METAL ASR; UNK HIP FEMORAL SLEEVE ASR; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White