MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ARTICUL/EZE BALL 28 +12 BLK; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number	1365-14-000
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Joint Dislocation (2374); Osteolysis (2377)
Date of Event	08/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The patient was implanted in (b)(6) 2018 for a total hip prosthesis on the left side because of the replacement of implant due to a metallosis.In (b)(6) 2021, highlighting of a recidivism of metallosis on a new implant.Functional damage since the middle of (b)(6) 2021 with a total and painful functional impotency leading to a ct-scan which showed a loosening of the acetabular implant.Removal of the prosthesis with femorotomy, enlarged synovectomy and placement of spacer.It is observed intraoperatively a significant metallic liquid collection, associated with a metallic infiltration of all tissues peri-prosthetic, as well as a mechanical conflict, causing metal / metal contact between the rod and the acetabulum.The explant carried the marks of this contact.The bacteriological samples collected are negative.A new pose of a prosthesis with a couple of ceramic-ceramic friction is considered.Doi: (b)(6) 2018.Dor: unknown.Left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned device did not identify any product defects or anomalies.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.
Event or Problem Description
Additional information received indicated the following: a.Can you please confirm if the products replaced on (b)(6) 2018 were depuy? if yes, please provide product and lot details or complaint number if previously reported.No, they were devices from the tornier company.B.Was there a surgical delay because of this event? if yes, what was the duration of the delay? no surgical delay but need for revision surgery.C.Please add to the follow-up: what was the reason for the removal of the prosthesis with femorotomy, enlarged synovectomy and placement of spacer? functional deterioration since mid-july with total functional impotence and pain resulting in a ct scan showing loosening of the acetabular implant.D.What date was this revision? (b)(6) 2021.E.Why was a spacer placed? after loosening of the prosthesis, awaiting reimplantation of left thp.F.Histology/pathology report:- - primary and/or revision microbiology reports, arthroscopy samples prior to revision, histology/pathology reports from revision.See document attached -operating report: result: the left femoral and gluteal soft tissue collections are noted.- the gluteal collection is measured at 144x107mmx53mm, stable.- superimposed appearance of the femoral collection, arising from the femoral vasculo-nervous bundle and ascending along the anterior aspect of the left psoas with a maximum diameter of 41 mm, accessible to echoguided puncture - clear increase in size of the collection projecting opposite the acetabulum and the proximal insertion of the quadriceps muscles, measured 54x100mm in a transverse plane accessible to puncture.- increased osteolysis of the left hip bone around the prosthetic acetabulum, with upward dislocation of the prosthetic complex.No abnormality of the right thp.Conclusion: increased osteolysis around the prosthetic acetabulum, resulting in a dislocation fracture with upper displacement of the left total hip prosthesis.Increased size of the collection in front of the acetabulum, and superimposable aspect compared to the ct scan of (b)(6) 2021 and other collections, accessible to ultrasound drainage.G.Ultrasound reports: echo/puncture biopsy report of the left hip collection on (b)(6) 2021 recurrence of metallosis on the new implant (inc 2021/0629 - r2113044) was detected in (b)(6) 2021.Functional degradation since mid-july with total functional impotence and pain leading to a ct scan showing loosening of the acetabular implant.H.Implant insertion op notes: please provide all notes relevant to the reported event for example: - - reason for implant insertion, device labels, surgery report, physiotherapy report, early falls and/or dislocations.Implant replacement after metallosis.I.Implant removal op notes:- please provide all notes relevant to the reported event for example: - - reason for revision, surgeon report and product and lot codes of devices remaining in situ.Recurrence of metallosis on the new implant (inc 2021/0629 - r2113044) was detected in (b)(6) 2021.Functional degradation since mid-july with total functional impotence and pain leading to a ct scan showing loosening of the acetabular implant." the follow-up information provided supports that there was very significant evidence of metallosis.The follow-up also reported that there was pain, and what was described as "functional impotence" of the hip--which indicates that the patient had a compromise to the function of their hip joint.There was also reported in the conclusion, that the osteolysis in the bone surrounding the acetabular cup resulted in a "dislocation fracture" with "upper displacement of" the left total hip prosthesis" (the loose cup).
Additional 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: b1 (is product problem), b5 and h6 (clinical codes).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 (device code).
Additional 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: ARTICUL/EZE BALL 28 +12 BLK
• Common Device Name: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): JJM (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou jiangsu 21512 -6; CH 21512-6
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12539521
• Report Number: 1818910-2021-21218
• Device Sequence Number: 14478904
• Product Code: JDI
• UDI-Device Identifier: 10603295033127
• UDI-Public: 10603295033127
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K883460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/07/2021

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
• Operator of Device: Health Professional
• Device Model Number: 1365-14-000
• Device Catalogue Number: 136514000
• Device Lot Number: D17020380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 10/11/2021; 10/25/2021; 11/29/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 10/22/2021; 11/10/2021; 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTICUL/EZE BALL 28 +12 BLK; CORAIL CEM STEM STD S11; ARTICUL/EZE BALL 28 +12 BLK; CORAIL CEM STEM STD S11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown