MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ6 HI OFF; HIP FEMORAL STEM

Catalog Number 157011120

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Anemia (1706); Bone Fracture(s) (1870); Hemorrhage/Bleeding (1888); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Ambulation Difficulties (2544); Muscle/Tendon Damage (4532); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/10/2011

Event Type  Injury  

Event Description

Although there are no patient specific allegations, general litigation alleges metal on metal.Update rec'd 8/6/2014- pfs and medical records received.Part/lot was provided.A correct doi and dor were provided.After review of the medical records the primary operative showed a crack occurred in the posterior calcar during the seating of the stem.The stem is being reported.The revision operative note indicated the patient had an infection and all implants were removed on (b)(6) 2010.The cup and 2 screws are being added to the complaint, but not reported as they have been implanted more than 3 months.It should also be noted the patient had a poly insert, not a metal insert.The patient was reimplanted on (b)(6) 2011.There is no new additional information that would affect the existing mdr decision.The complaint was updated on: (b)(6) 2014.

Manufacturer Narrative

Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

(b)(4).No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Corrective action was not indicated.Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

Udi: (b)(4).

Manufacturer Narrative

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.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.

Event Description

Pfs alleges hip pain, infection, inability to stand for long hours and ongoing hip pain and inability to work full time.In addition to what were previously reported and after review of the medical records the patient was revised due to walking difficulty and patient had anemia secondary to acute surgical loss.Clinical visit reported peroneal tendinitis.Operative note reported a large amount of scarce was removed bone loss from the calcar.Patient had anemia secondary to acute surgical loss.Clinical visit reported peroneal tendinitis and abrasion around the hip.

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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the tendon and bone injury, corrected: g1.

• Brand Name: SUMMIT POR TAPER SZ6 HI OFF
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 4039374
• MDR Text Key: 4728772
• Report Number: 1818910-2014-26691
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK001991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/06/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 157011120
• Device Lot Number: D5LH41
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2014
• Initial Date FDA Received: 08/26/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; 04/10/2019; 11/14/2019; 10/04/2021
• Supplement Dates FDA Received: 09/04/2014; 10/24/2015; 05/06/2019; 11/20/2019; 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX +4 10D 40IDX58OD; ASPHERE M SPEC 12/14 40 +5; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX35MM; PINNACLE SECTOR II CUP 58MM
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 95