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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 HIP BA BIO 28MM 12/14 + 5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
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DEPUY INTERNATIONAL LTD - 8010379 HIP BA BIO 28MM 12/14 + 5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS Back to Search Results
Catalog Number 9111122
Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988); Noise, Audible (3273)
Patient Problems Edema (1820); Necrosis (1971); Seroma (2069); Joint Dislocation (2374); No Code Available (3191)
Event Date 03/11/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).The devices were reviewed by bioengineering and a report was received stating it is unlikely that a potential product issue was present.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Revision of hip-tep (inlay and head) left side as pe inlay disassociated from the cup.The head caused metal wear at the inner side of the pinnacle cup.Doi: unknown, dor: (b)(6) 2019.
 
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.¿ no code available is used to capture extraskeletal ossification, bone disorder, joint injury, device revision or replacement.
 
Event Description
After review of clinical report, patient was revised to address mechanical complication, hip tep, and pe inlay luxated and abrasion of cup against the ceramic head, left hip tep.The ct examination of boney pelvis on (b)(6) 2019 showed a status post hip tep implantation, left with firm fit of the shaft and the prosthetic cup.Eccentric posterior apical position of the prosthesis head in the cup due to dislocation or rotation of the inlay toward ventral from the cup, an inlay fracture cannot be ruled out.In axial slicing, fluid retention measuring 6.5 x 4 x 7 cm lateral of the left greater trochanter, dd: seroma in the surgical access route.Moderate cox arthrosis, right.Isg arthrosis bilaterally.Erosive osteochondrosis l5/s1 and facet joint arthrosis l3 to s1.Doi: (b)(6) 2019 - dor: (b)(6) 2019 (left hip).
 
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.
 
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: corrected: a2 (birth date).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the devices were reviewed by bioengineering and a report was received stating it is unlikely that a potential product issue was present.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Updated 02 november 2020 re-open.The complaint was re-opened upon receiving further correspondence.The information received did not change the original investigation report.
 
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Brand Name
HIP BA BIO 28MM 12/14 + 5
Type of Device
ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK  LS11 8DT
MDR Report Key9889211
MDR Text Key186750571
Report Number1818910-2020-09464
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2023
Device Catalogue Number9111122
Device Lot Number9005716
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2019
Date Manufacturer Received11/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
APEX HOLE ELIM POSITIVE STOP; CORAIL2 STD SIZE 13; CUP 121701050/8947808; HOLE ELIMINATOR 124603000/D18070248; LINER 121928050/J00853; PINN MAR NEUT 28IDX50OD; PINNACLE 100 ACET CUP 50MM; STEM 3L92513/8801574
Patient Outcome(s) Required Intervention;
Patient Age77 YR
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