MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 DELTA CER HEAD 12/14 28MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number 136528320

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Host-Tissue Reaction (1297); Adhesion(s) (1695); Cyst(s) (1800); Headache (1880); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Weakness (2145); Distress (2329); Discomfort (2330); Injury (2348); Hypoesthesia (2352); Joint Disorder (2373); Palpitations (2467); Ambulation Difficulties (2544)

Event Date 11/11/2016

Event Type  Injury  

Manufacturer Narrative

(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

Summit litigation received.Litigation alleges pain, injury, loss range of motion, elevated metal ions, inflammation, swelling, and mental anguish.Pathology studies of excised tissues ascertained "black metallic prosthetic particles." lab test shows metal ion levels were below 7 ppb.Doi: (b)(6) 2012; dor: (b)(6) 2016; right hip.

Manufacturer Narrative

(b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.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.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(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

Medical records received.After review of medical records, the medical records provided are surgical pathology reports from (b)(6) 2016.Specimens submitted were a.Right hip bursa and b.Explanted right hip implants.Report indicates pigment deposition, papillary hyperplasia, fibrosis and fibrin deposition.Another report from (b)(6) 2017 indicates fibrocapsular tissue pigment (pseudocapsule) and explanted right femoral head, liner and stem.

Event Description

Medical records received.Radiologic consultation report on (b)(6) 2016 indicated that a right adnexal cyst was present within the pelvis.Patient visit on (b)(6) 2016 reports that the patient had difficulty mobilizing.On another visit last on (b)(6) 2016, mechanical clicking was present on the right hip with rom as well as significant weakness of the hip flexor tendon attributed to the large femoral head.Physician notes during on (b)(6) 2016 visit indicate that there is some fluid collection consistent with trunnionosis.Patient also reports discomfort.Patient also complains about instability, distress numbness, palpitations and headaches.

Manufacturer Narrative

Product complaint#: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: added: age or date of birth, event, other relevant history, brand name, common device name, procode (lot, catalog, udi, expiration date),device manufacture date and (patient codes).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.

Event Description

Medical records received.After review of medical records, clinic visits reported that patient had some bladders issues, pain, and dislocating hip but surgeon stressed that it may be feeling subluxation or tendon snapping.It was also confirmed that acetabular components were non-depuy.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: open action for medical record review.No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.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.

• Brand Name: DELTA CER HEAD 12/14 28MM +5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork IN ; EI
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 7738322
• MDR Text Key: 115654395
• Report Number: 1818910-2018-65519
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: 136528320
• Device Lot Number: 3305163
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female