MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US EA DELTA CER INSERT 36IDX52OD; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS

Catalog Number 121881752

Device Problem Fracture (1260)

Patient Problem Not Applicable (3189)

Event Date 01/01/2019

Event Type  malfunction  

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

The agent reported that during hip prosthesis surgery on (b)(6) 2019 at cdc sanatorio trieste first operator sabino fiume in the insertion phase of the biolox delta ceramax 121881752 lot 9184531 inside the cup the insert was chipped on the edge.It was therefore, necessary to remove the insert, and open biolox delta ceramax 121881752 lot 9158126.However, biolox delta ceramax 121881752 lot#: 9158126 was also crushed during insertion into the cup.The agent pointed out that the first operator performed insertion of the ceramic insert into the cup following the surgical technique correctly.The operation ended by inserting a polyethylene insert, and no damage to the patient was reported.

Manufacturer Narrative

Product complaint # (b)(4).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.Added: device available for evaluation.Corrected: device evaluated by mfr.

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.Additional narrative: product complaint # (b)(4).Investigation summary investigation of the returned products identified, through metal transfer on the ceramic liners, that in both cases the inserts appear to have fractured due to misalignment of the liners inside the cup.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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.The liners shall be retained for future reference.The complaint was received into the company with the following comment: the agent reported that during hip prosthesis surgery on 09/16/2019 at cdc sanatorio trieste first operator sabino fiume in the insertion phase of the biolox delta ceramax 121881752 lot 9184531 inside the cup the insert was chipped on the edge.It was therefore necessary to remove the insert and open biolox delta ceramax 121881752 lot 9158126.However, biolox delta ceramax 121881752 lot 9158126 was also crushed during insertion into the cup.The agent pointed out that the first operator performed insertion of the ceramic insert into the cup following the surgical technique correctly.The operation ended by inserting a polyethylene insert and no damage to the patient was reported both products were returned for investigation and they were forwarded onto the supplier for further analysis.The products involved were: delta cer insert 36idx52od code 121881752, lot 9184531.Delta cer insert 36idx52od code 121881752, lot 9158126.A worldwide complaint database search found no previous related reports against the provided product code / lot code combinations.The suppliers report, attached in attachments titled (b)(4) final report kiv 19 10 31, summarised: the component properties and the microstructure as obtained from the quality documents of both inserts fulfill the requirements as specified at the time of production.There are no indications of any pre-existing material defect.Primary regular metal transfer cannot be found on any of the inserts.The existing metal transfer indicates a misaligned position of the insert in the metal cup for both inserts.Both inserts seem to be fractured due to similar reasons: due to the misalignment there were point contacts between the metal cup and the insert which may have initiated the fracture.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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: EA DELTA CER INSERT 36IDX52OD
• Type of Device: PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9175418
• MDR Text Key: 215571353
• Report Number: 1818910-2019-109150
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 121881752
• Device Lot Number: 9158126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Date Manufacturer Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1