MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 TRI-LOCK BPS SZ 4 HI OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Catalog Number 101214040

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Fall (1848); Unspecified Infection (1930); Inflammation (1932); Muscle Spasm(s) (1966); Muscular Rigidity (1968); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Tissue Damage (2104); Weakness (2145); Injury (2348); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 11/02/2015

Event Type  Injury  

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 Description

Litigation received.Litigation alleges pain, swelling, inflammation, infection and damage to surrounding bone and tissue, multiple dislocations and lack of mobility.

Manufacturer Narrative

(b)(4).

Event Description

Pfs and medical records received.There is no new pfs allegation.After the review of medical records for reportability, patient was revised to address painful right total hip replacement.Revision notes stated that there was minimal evidence of metal on metal disease.Clinic visit reported of continued elevated metal ions, pain, weakness, stiffness and instability leading to difficulty walking or climbing stairs, decrease range of motion and pain is worse with hip flexion.Cobalt and chromium are above 7pbb.

Event Description

Plaintiff¿s fact sheet received.In addition to what were previously alleged, pfs alleges bodily injuries including muscle spasms, neuropathy, muscle atrophy, falls, damage to other limbs including knee and back issues, and impaired adl.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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.

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 # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TRI-LOCK BPS SZ 4 HI OFFSET
• Type of Device: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 7074423
• MDR Text Key: 93444333
• Report Number: 1818910-2017-50558
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K073570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2019
• Device Catalogue Number: 101214040
• Device Lot Number: D46B21
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 93