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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Bone Fracture(s) (1870); Osteolysis (2377); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 12/22/2008

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

The literature article entitled, "cementless total hip replacement: past, present, and future" written by harumoto yamada, yasuo yoshihara, osamu henmi, mitsuhiro morita, yuichiro shiromoto, tomoki kawano, arihiko kanaji, kennichi ando, masato nakagawa, naoto kosaki, and eiichi fukaya published by the journal of orthopaedic science j orthop sci (2009) 14:228¿241 doi: 10.1007/s00776-008-1317-4 accepted by publisher 22 december 2008 was reviewed for mdr reportability.The article's purpose is to report on the history and changes of th procedure, achievements and problems of the current models, and new attempts of cementless thr.The report provides a wide range and large volume of studies and results over the range of 1995 to 2006.Depuy products are mentioned within the article with focus on aml a stem, duraloc cup, and tri-lock cup.The article heavily focuses on performances on depuy products for performances regarding as current products including wear rates.No mention of material debris.The article discusses bone absorbency extensively and provides a summary of noted adverse events over time periods of 5 years, 10 years and greater than 15 years post initial implantation for both cementless cups and stems: implant wear of bearing surfaces, disruption (dissociation) of locking mechanism, osteolysis, loosening, femoral intra-operative fracture, femoral stress shielding, femoral fracture due to stress shielding.Table 2 on page 237 provides information that some revisions were due to aseptic loosening of cup and stem.The article does not provide adequate information to determine exact quantities of products as patients may experience more than one adverse events.The article does not provide information regarding interventions for adverse events.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint #
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> (b)(4).Investigation summary
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> no device was received.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.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9216630
• MDR Text Key: 163117301
• Report Number: 1818910-2019-110974
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention