MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US AML HIGH OFFSET LG STAT 22.5MM; AML IMPLANT : HIP FEMORAL STEM

Catalog Number 155403225

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Hypersensitivity/Allergic reaction (1907); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Ambulation Difficulties (2544); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)

Event Date 07/07/2016

Event Type  Injury  

Event Description

Pinnacle metal on metal litigation received.Litigation alleges injury, pain, discomfort, tenderness, stiffness, decreased range of motion, difficulty rotating the hip joint, difficulty bearing weight, and difficulty ambulating, loss of mobility, mental anguish, disfigurement, and emotional distress.Doi: (b)(6) 2008; dor: (b)(6) 2016; left hip.

Manufacturer Narrative

Product complaint # (b)(4).E3 initial reporter occupation: lawyer.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

Event Description

After review patient was revised due to failed metal-on-metal total left arthroplasty with recurrent dislocation and elevated serum cobalt and chromium.The patient also had pseudotumor with deficient abductors which was excised.The femoral head was removed.The femur was dissected in preparation for extended trochanteric osteotomy.Bur and flexible osteotomies were used to break up the bone-implant interface.The femoral stem was eventually removed.Prior scar tissue was excised.An acetabular explant system was used to remove the cup with minimal bone loss.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not perform as part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: AML HIGH OFFSET LG STAT 22.5MM
• Type of Device: AML IMPLANT : HIP FEMORAL STEM
• 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 ; 3035526892
• MDR Report Key: 18623376
• MDR Text Key: 334328493
• Report Number: 1818910-2024-02182
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295058502
• UDI-Public: 10603295058502
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012364
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2011
• Device Catalogue Number: 155403225
• Device Lot Number: AR9GH1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 02/06/2024
• Supplement Dates FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2006
• 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: 12/14 ARTICUL 40MM M SPEC+5; APEX HOLE ELIM POSITIVE STOP; PINNACLE 100 ACET CUP 56MM; PINNACLE MTL INS NEUT40IDX56OD
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male