MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER METAL PINNACLE; FEMORAL SLEEVE

Catalog Number UNK HIP ACETABULAR LINER METAL

Device Problem 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); 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.(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 andthe 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: (b)(6) 2003.Dor: (b)(6) 2018.Right hip.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

(b)(6) medical records note the patient has left hip and left knee pain.(patient¿s native hip and knee).

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.H10 additional narrative: 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.

• Brand Name: UNK HIP ACETABULAR LINER METAL PINNACLE
• Type of Device: FEMORAL SLEEVE
• 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: 12661055
• MDR Text Key: 277457361
• Report Number: 1818910-2021-22972
• 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: Other,Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER METAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2024
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White