MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS

Catalog Number UNK HIP ACETABULAR LINER

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Hemorrhage/Bleeding (1888); Joint Dislocation (2374)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Literature article entitled ¿total hip arthroplasty with subtrochanteric shortening osteotomy in patients with high hip dislocation secondary to childhood septic arthritis: a matched comparative study with crowe iv developmental dysplasia.¿ written by park cw, lim sj, cha yt, park ys.J arthroplasty.Published 22 aug 2019.2020.Pmid: 31521447.The article's purpose was to ¿compare the clinical and radiographic results of cementless tha with sso in high hip dislocation that resulted from childhood septic arthritis and crowe iv ddh with a mean follow-up period of 12 years.¿ patient data specific: patient 1: (b)(6) man with history of a right septic natural hip.Patient 2: (b)(6) woman with history of highly dislocated hip, childhood infection of the natural hip.Patient data non-specific: 12 men and 46 women with a mean age of 41.3 years.The mean body mass index was 22.9 kg/m2, and the mean duration of follow-up was 12.3 years.It is noted that implants in the study were a combination of depuy and competitor products.Depuy products: pinnacle and duraloc cups, cementless s-rom stems.It is reasonable to conclude depuy heads and liners would be used in conjunction with the cups and stems.Adverse events specific patients: patient 1: persistent thigh pain with delayed union of osteotomy ¿ treated with orif.Patient 2: pain, subsidence and loosening of the stem ¿ revision.Adverse events non-specified patients: intra-op blood loss requiring - transfusion of packed red blood cells.Stem subsidence greater than 3 mm ¿ no intervention noted.Sciatic and femoral nerve palsy ¿ no intervention noted, recovered spontaneously within 1 year without residual symptoms.Pain and delayed radiographic union of osteotomy ¿ additional surgical fixation of osteotomy.Aseptic stem loosening ¿ femoral revision.Dislocation ¿ revision.Ceramic head fracture ¿ revision.Aseptic cup loosening ¿ revision.Dissociation ¿ revision.Literature is a valuable source of information.However, it has limitations, including nonspecific and indeterminate information about each adverse event.The authors do not provide information to identify the devices used during primary procedure for each patient.The adverse events captured in this complaint are the events that could be associated with the noted depuy synthes devices.The events that are associated with competitor devices are excluded from this complaint.The actual number and specific product line of depuy synthes devices associated with the above adverse events is unknown.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.All available x-rays were reviewed, and there is no progressive evidence that confirms a implant dislocation nor the implant disassociation allegation.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.Device history lot : a manufacturing records evaluation (mre) was not performed as no finish goods lot number or product code was provided for this device.

• Brand Name: UNKNOWN HIP ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• 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 46581-0988 ; 3035526892
• MDR Report Key: 14141542
• MDR Text Key: 289500633
• Report Number: 1818910-2022-06983
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2022

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 ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/19/2022
• Supplement Dates Manufacturer Received: 06/28/2022
• Supplement Dates FDA Received: 06/28/2022
• 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