MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX58OD; METAL ACETABULAR LINER

Catalog Number 121887458

Device Problem Naturally Worn (2988)

Patient Problems Wound Dehiscence (1154); Ossification (1428); Adhesion(s) (1695); Fall (1848); Fatigue (1849); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Pocket Erosion (2013); Loss of Range of Motion (2032); Scar Tissue (2060); Synovitis (2094); Distress (2329); Osteolysis (2377); Numbness (2415); Ambulation Difficulties (2544); Joint Laxity (4526); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Unspecified Tissue Injury (4559); Physical Asymmetry (4573); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/16/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

Litigation record received.Patient had excessive amounts of cobalt and chromium to wear from the surface of the acetabular insert and from the femoral head, which in turns causes the hip implant to fail and the surrounding tissue and bone to die, tissue and bone destruction, and pain and suffering.Patient had a pathologic fracture through the anterior wall of the left acetabulum secondary to osteolysis in the setting of alval/metallosis.Plaintiff sustained and continues to suffer economic damages, severe and possibly permanent injuries, pain, suffering and emotional.Distress.Doi: (b)(6) 2009, dor: (b)(6) 2021, left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this complaint was not returned.X-ray evidence provided was reviewed and found nothing indicative of a device nonconformance.The reported condition was not confirmed.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 (121887458/2814475) product and lot numbers, and no non-conformances 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.H10 additional narrative: added: b5, h6 (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

Emergency department notes on (b)(6) 2020 stated that the patient fell a month ago and had pain in the right hip that radiated to the right knee.Due to the pain in the hip, the patient had limited ability to ambulate.There were no allegations that any invasive treatment, nor permanent injury occurred due to the fall this time.There were no fractures and no allegations that depuy products malfunctioned in any way.

Event Description

Medical records received.The patient was implanted with pinnacle mom and trilock stem.The patient had left hip joint capsular synovitis and pseudotumor and fluid collection.Pain is accompanied by instability, numbness and weakness, erosion, glut medius tendonitis, and pain with resisted abduction, swelling, and loss of motion, the pain increased when walking, with burning and numbness in the anterolateral thigh and left greater than right, possible lucency and bone lysis.

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: a2 dob, a3, b5, b7, d4 (lot, catalog, udi), g4 (pma/ 510(k)), h4, h6 (health effect - clinical code) h6: unspecified tissue injury (e2015) is being utilized to capture bone injury & soft tissue injury.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: a1, d1, d2a, d10 (concomitant), g1.

Event Description

After a review of the medical records, the patient was revised to address the pseudotumor left hip.Operative note reported large pseudotumor left hip with complete involvement of capsule, 2-3 cm hip shortening due to previous hip center elevation, minimal metallosis staining of soft tissues.

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, d4 (expiration date) and h6 (clnical codes) 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 were received and stated the following: in addition to what was previously reported in the medical records, after review of the records, operative findings reported large pseudotumor left hip with complete involvement of capsule; 2-3 cm shortening due to previous hip center elevation and minimal metallosis staining of soft tissue.Fascia was encountered and was incised in line with the skin incision sharply, subfascial adhesions were mobilized.The scar, was debrided and multiple culture collected.There were 2 screws in the cup both had backed out slightly.They were tightened and fully seated.There was an osseous defect inferior and deep to cup, soft tissue sleeve remnant that was repaired.Surgery pathology reported fibrous tenosynovial tissue with necrosis and dystrophic calcification, negative for neoplasm.Clinical visit prior to revision reported impaired mobility, loss of protective sensation, cognition deficits, balance deficits and weakness.Ct scan on (b)(6) 2020 reported bone demineralization.There is an associated pathologic fracture involving the anterior wall of the left acetabulum secondary to osteolysis setting of alval/metallosis.Moderate left hip joint capsular synovitis, associated dehiscence of the posterior lateral left hip capsule, joint fluid.These findings are suggestive of underlying alval/metallosis associated with left tha.

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.

• Brand Name: PINNACLE MTL INS NEUT40IDX58OD
• Type of Device: METAL ACETABULAR LINER
• 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 IN LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13043911
• MDR Text Key: 282603399
• Report Number: 1818910-2021-28458
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2013
• Device Catalogue Number: 121887458
• Device Lot Number: 2814475
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 12/14 ARTICUL 40MM M SPEC+5; 12/14 ARTICUL 40MM M SPEC+5; PINN CAN BONE SCREW 6.5MMX30MM; PINN CAN BONE SCREW 6.5MMX30MM; PINN CAN BONE SCREW 6.5MMX40MM; PINN CAN BONE SCREW 6.5MMX40MM; PINNACLE MTL INS NEUT40IDX58OD; PINNACLE SECTOR II CUP 58MM; PINNACLE SECTOR II CUP 58MM; TRI-LOCK BPS SZ 4 STD OFFSET; TRI-LOCK BPS SZ 4 STD OFFSET; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 67 KG