MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL STEM SROM

Catalog Number UNK HIP STEM SROM

Device Problems Fracture (1260); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Naturally Worn (2988); Osseointegration Problem (3003)

Patient Problems Foreign Body Reaction (1868); Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); Osteolysis (2377); Inadequate Osseointegration (2646); Joint Laxity (4526)

Event Date 01/01/2018

Event Type  Injury  

Event Description

"this complaint is from a literature source.The following literature cite has been reviewed: matharu gs, hunt lp, murray dw, howard p, pandit hg, blom aw, bolland b, judge a.Is the rate of revision of 36 mm metal-on-metal total hip arthroplasties with pinnacle acetabular components related to the year of the initial operation? an interrupted time-series analysis using data from the national joint registry for england and wales.Bone joint j.2018 jan;100-b(1):33-41.Doi: 10.1302/0301-620x.100b1.Bjj-2017-0625.R2.Pmid: 29305448.Objective and methods the aim of this study was to investigate whether the five-year revision rates for 36 mm mom thas with pinnacle acetabular components, and for a control group of all other mom thas, were higher in primary thas undertaken between 2004-2012.All information on the revisions was obtained via the national joint registry for england and wales.The study group compared the all-cause revision rates for 11, 826 pinnacle 36-mm acetabular mom thas that utilized either the corail stem or the srom stem/sleeve combination with the ultamet liner and articul/eze femoral head with the control group that included 14,934 asr resurfacing construct and other unspecified depuy mom tha constructs.The authors do not provide sufficient information to determine the specifics of the 1190 reported revisions.This complaint will capture each reported reason for revision with a quantity of 1.The actual number of products revised in each revision are unknown.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: pinnacle cup, 36-mm ultamet metal acetabular liner, articul/eze femoral head, corail femoral stem, s-rom femoral stem/sleeve combination, asr resurfacing cup and femoral component.Adverse event(s) and provided interventions associated with depuy devices: all-cause reasons for revision: unknown number associated with foreign body reaction 578 to treat armd- the authors note the metal debris could be generated from the cup, head, liner, and/or stem, 252 revisions to treat pain, 202 revisions to treat loosening of an unspecified component.The authors note there were revisions for loosening of the stem, the cup, or both.96 revisions to treat dislocation and/or subluxation/instability, 93 revisions to treat infection, 76 revisions to treat malpositioning of an unknown device, 56 revisions to treat periprosthetic fracture of the femur and/or acetabulum, 46 revisions to treat unspecified osteolysis, 44 revisions for wear of an unknown device, 14 revisions to treat fracture of an unspecified implant, 8 revisions to treat head/socket mismatch, 178 revisions for unknown reasons".

Manufacturer Narrative

Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.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
=
> no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot
=
> a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK HIP FEMORAL STEM SROM
• Type of Device: FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16022520
• MDR Text Key: 305887025
• Report Number: 1818910-2022-25883
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2022

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 Catalogue Number: UNK HIP STEM SROM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 12/22/2022
• Supplement Dates FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention