MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICUL/EZE BALL 28 +5 BR; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-12-000

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Joint Dislocation (2374); Joint Laxity (4526); Muscle/Tendon Damage (4532); Unspecified Musculoskeletal problem (4535); Unspecified Tissue Injury (4559); Physical Asymmetry (4573)

Event Date 07/08/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Ppf, pfs and medical records received.Ppf alleges component fracture, dislocation with closed reduction, and elevated metal ions.Pfs alleges hip dislocation, bone and muscle damage, pain and limited range of motion.After review of the medical records the patient was revised to address periprosthetic hip recurrent instability, dislocation, disruption of constrained liner with subluxed, extensive osteolysis in the femur and acetabulum and slightly elevated metal ions.Operative note reported some moderate tendinopathy due to metal wear debris from old surgery, scar tissues around the acetabulum and femur.Some metal pieces not recovered due to risk damage the sciatic nerve and vital structures.Acetabular device had significant amount of anteversion; summit stem was impinging the posterior rim of the cup.There was a moderate size notch on the stem.Doi: (b)(6) 2018 dor: (b)(6) 2021 right hip 2nd revision.

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 : 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.

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:  h6 clinical code: unspecified musculoskeletal problem (e1635) is used to capture joint injury and joint disorder.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Patient was revised on (b)(6) 2021 to address instability, recurrent right hip dislocations and a fractured constrained liner, as a salvage procedure.She presented with a leg length discrepancy, long on the right.Intraoperatively, the broken constrained liner was explanted, but some metal fragments of the liner could not be safely recovered and were left in-situ.The acetabular cup was found to be significantly anteverted in position, and it was identified that the femoral neck of the summit femoral stem impinged on the posterior rim of the cup when the patient's leg was placed in extension, impinging at 1 to 2 degrees of extension.There was evidence of a moderate sized notch on the posterior aspect of the stem.It was decided though to retain the well-fixed stem.The cup was extracted and a 58 mm cup implanted to 45 degrees abduction.A dual mobility liner was placed along with +8.5 mm femoral head, remaining long on the right to achieve stability.There were no reported complications.

• Brand Name: ARTICUL/EZE BALL 28 +5 BR
• 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 INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14349471
• MDR Text Key: 291328427
• Report Number: 1818910-2022-08584
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033080
• UDI-Public: 10603295033080
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K843909
• 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
• Report Date: 05/10/2022

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 Model Number: 1365-12-000
• Device Catalogue Number: 136512000
• Device Lot Number: D16120259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2022
• Initial Date FDA Received: 05/10/2022
• Supplement Dates Manufacturer Received: 04/21/2022; 05/23/2022
• Supplement Dates FDA Received: 05/12/2022; 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2016
• 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: PINN LNR CON +4 10D 28IDX50OD.; PINNACLE SECTOR II CUP 50MM.; SUMMIT POR TAPER SZ3 HI OF.
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 69 KG