MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM -2; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-50-000

Device Problem Naturally Worn (2988)

Patient Problems Erythema (1840); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Distress (2329); Ambulation Difficulties (2544); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/07/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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.

Event Description

Pinnacle mom litigation record received.Litigation alleges heavy metal poisoning from toxic heavy metals resulting to muscle, tissue injury, pain, metal wear, scar tissue formation, limited adl, emotional trauma and distress.Doi: (b)(6) 2013.Dor: (b)(6) 2021.Right hip.

Manufacturer Narrative

Product complaint # (b)(4).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.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

Manufacturer Narrative

Product complaint # (b)(4).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.Device history lot : a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.

Manufacturer Narrative

Product complaint # (b)(4).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.Device history lot : a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.

Event Description

Medical records were received and stated the following: after review, patient was revised due to progressive soft tissue mass about his lateral hip and increasing pain.Laboratory studies were consistent with metollosis from his metal-bearing wear.There was a very large volume of hemorrhagic- and necrotic-appearing tissue.The surgeon initially worked to excise this, and had excised the pseudotumor, the surgeon identified the fascia, and the fascia was incised longitudinally.There was necrosis of the abductor complex.

Event Description

Medical records received indicate that on (b)(6) 2021: the patient developed a hematoma in the right hip requiring debridement and head and liner exchange.Iv antibiotics were given postoperatively.He is diagnosed with enterobacter septic arthritis.On (b)(6) 2021: the patient has had persistent wound drainage and elevated inflammatory markers since the (b)(6) 2021 i&d and a repeat aspiration revealed a deep hip infection.He underwent a revision on (b)(6) 2021 of all implants.During the removal of the stem, the calcar was fractured requiring two cables to fixate the bone.Postoperatively, excessive drainage from the wound occurred requiring a wound vac to be placed.On (b)(6) 2021: final implants are placed.An area of nonhealing of the previous incision was identified, though no intervention was noted.

Manufacturer Narrative

Product complaint #(b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.All available x-rays evidence were reviewed, and nothing indicative of a device nonconformance was observed, therefore the reported allegation 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 (mre) will not be performed since mom systems are obsolete.

Event Description

Medical records reviewed.(b)(6) 2007 left implant surgery (no specific info provided).On (b)(6) 2013 right implant surgery (no specific info provided).On (b)(6) 2021 the patient right total hip revision, for metallosis and pseudotumor.Revision of head and liner along with extensive debridement of necrotic muscle, fascia, and capsule.Patient was revised to a ceramic and polyethylene bearing.(no mention of manufacturer).On (b)(6) 2021 the patient had a right re-revision with hematoma excision, irrigation and debridement with head and liner exchange (no specifics provided).On (b)(6) 2021, medical records note the patient had persistent drainage from the right hip wound.Thick drainage of thick yellow material since the last surgery on (b)(6) 2021.On (b)(6) 2021, the patient had a right hip aspiration.On (b)(6) 2021, medical records notes that the patient reports having some pain in the right hip, there is some redness around the distal end of the incision.Drainage stopped (b)(6) 2021.On (b)(6) 2021 right extended recovery, revision surgery stage 1 due to infection.Patient underwent resection arthroplasty with placement of an antibiotic spacer.During the revision, significant purulent fluid and material was found.There was minimal attached bone, but there was a crack in the region of the calcar that was noted during extraction of femoral component.Cerclage cable was placed around calcar fracture proximally and then the stem was placed.On (b)(6) 2021 right revision surgery stage 2.The patient had a right total hip arthroplasty reimplantation as the patient had a cleared infection.Depuy components were implanted during hit procedure.

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.On (b)(6) 2021, patient had a clinic visit and reported postoperative amount of surgical site drainage and evaluated.Has developed increasing pus type drainage, low-grade fevers of 100, increasing pain.Difficulty in walking.Pain is achy and sharp.Redness around the incision site.On (b)(6) 2021, patient experience bleeding from incision site.On (b)(6) 2021, patient had pain in right hip and mass at the right hip.Patient lab results were on (b)(6) 2021, undergone right hip examination and findings of large palpable mass at the level of the trochanter in the lateral hip.Patient has elevated serum cobalt and serum chromium.

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: ARTICULEZE M HEAD 36MM -2
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14165894
• MDR Text Key: 289731063
• Report Number: 1818910-2022-07159
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295033899
• UDI-Public: 10603295033899
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980513
• 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: 04/21/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2015
• Device Model Number: 1365-50-000
• Device Catalogue Number: 136550000
• Device Lot Number: 3204255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/05/2022
• Initial Date FDA Received: 04/21/2022
• Supplement Dates Manufacturer Received: 04/05/2022; 03/13/2023; 03/16/2023; 04/19/2023; 08/17/2023; 09/15/2023
• Supplement Dates FDA Received: 04/25/2022; 03/15/2023; 03/17/2023; 04/24/2023; 09/05/2023; 10/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ARTICULEZE M HEAD 36MM -2; PINNACLE MTL INS NEUT36IDX52OD; PINNACLE SECTOR II CUP 52MM; SUMMIT POR TAPER SZ4 HI OFF; UNK HIP ACETABULAR LINER METAL PINNACLE; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male